3,090 West Pharmaceutical Services jobs in the United States
Clinical Research Regulatory Affairs Specialist
19133 Philadelphia, Pennsylvania
University of Pennsylvania
Posted 15 days ago
Job Viewed
Job Description
University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job Title
Clinical Research Regulatory Affairs Specialist
Job Profile Title
Clinical Research Regulatory Specialist B
Job Description Summary
Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn),regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.
Job Description
Job Responsibilities
+ Participate in the coordination of unit/division clinical research, including but not limited to Phase I-IV clinical trials.
+ Prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees.
+ Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and required governmental agencies, as well as, organize and maintain all regulatory affairs documentation/investigator site files (ISF) as required.
+ Resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits related to the conduct of the research at the site.
+ Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings.
+ Facilitate the development unit guidance/process documents including work tools, and development/maintenance of study specific case report forms, as well as, to provide direct regulatory/compliance guidance.
+ Perform additional regulatory duties as assigned.
Qualifications
+ Bachelor's degree and 3-5 years of research experience or equivalent combination of education and experience is required . At least 1 year of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.
This position is contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$62,000.00 - $63,600.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.
Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law .
Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
+ Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
+ Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
+ Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
+ Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
+ Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
+ Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
+ Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
+ University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
+ Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
+ Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
+ Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
+ Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: University of Pennsylvania's special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the University's commitment to excellence in teaching, research, and scholarship. The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status, or any class protected under applicable federal, state or local law.
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job Title
Clinical Research Regulatory Affairs Specialist
Job Profile Title
Clinical Research Regulatory Specialist B
Job Description Summary
Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn),regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.
Job Description
Job Responsibilities
+ Participate in the coordination of unit/division clinical research, including but not limited to Phase I-IV clinical trials.
+ Prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees.
+ Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and required governmental agencies, as well as, organize and maintain all regulatory affairs documentation/investigator site files (ISF) as required.
+ Resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits related to the conduct of the research at the site.
+ Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings.
+ Facilitate the development unit guidance/process documents including work tools, and development/maintenance of study specific case report forms, as well as, to provide direct regulatory/compliance guidance.
+ Perform additional regulatory duties as assigned.
Qualifications
+ Bachelor's degree and 3-5 years of research experience or equivalent combination of education and experience is required . At least 1 year of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.
This position is contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$62,000.00 - $63,600.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.
Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law .
Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
+ Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
+ Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
+ Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
+ Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
+ Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
+ Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
+ Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
+ University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
+ Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
+ Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
+ Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
+ Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: University of Pennsylvania's special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the University's commitment to excellence in teaching, research, and scholarship. The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status, or any class protected under applicable federal, state or local law.
View Now
0
Intern - Regulatory Affairs
21276 Baltimore, Maryland
Labcorp
Posted today
Job Viewed
Job Description
Intern - Regulatory Affairs at Labcorp summary:
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
View Now
1
Intern - Regulatory Affairs
21276 Baltimore, Maryland
Labcorp
Posted today
Job Viewed
Job Description
Intern - Regulatory Affairs at Labcorp summary:
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
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Regulatory Affairs Specialist
19488 Norristown, Pennsylvania
Jacobs Management Group, Inc.
Posted today
Job Viewed
Job Description
Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, you’ll play a critical part in bringing transformative orthopedic technologies to market, helping surgeons deliver better outcomes, faster recovery times, and higher quality of life for those with musculoskeletal conditions.
Why You Should Apply
- Join a company that thrives on innovation and real-world patient impact
- Collaborate with cross-functional experts in a fast-paced, clinical product environment
- Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices
- Enjoy a culture that blends urgency, teamwork, and a passion for clinical results
What You’ll Be Doing
- Drafting and submitting 510(k), IDE, and PMA regulatory submissions
- Partnering with Product Development teams to align on regulatory strategy
- Reviewing clinical data and collaborating with internal teams to support submissions
- Maintaining PMA records, preparing supplements and annual reports
- Training team members and contributing to SOP development and regulatory compliance
About You
- Be able to do the job as described
- Bachelor’s in health/science-related field; Engineering degree is a plus
- 2-5 years’ experience in Regulatory Affairs in the medical device industry
- Knowledge of orthopedic medical devices is highly preferred
- Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)
- Strong documentation, review, and cross-functional communication skills
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3
Regulatory Affairs Manager
94420 Foster City, California
ACL Digital
Posted today
Job Viewed
Job Description
Job title: PRC Submission Management Lead
Location: Foster City, CA
Duration: 06+ Months
Client is seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with a strong operational focus. The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows.
Key Responsibilities
• Serve as a Subject Matter Expert (SME) in US CPC team, ensuring compliance with regulatory standards and internal processes.
• Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault.
• Attend PRC meetings to represent submission status, clarify content, and capture feedback.
• Triaging and managing review comments from MLR teams, including coordinating re-review cycles and working closely with agencies or the Content Production Center (CPC) to ensure timely closure.
• Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness.
• Provide training and guidance to CPC team members on regulatory guidelines and best practices.
• Develop a playbook outlining optimal ways of working across PRC and CPC teams.
• Collaborate with Gilead’s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.
Qualifications
• Proven experience in US Commercial Regulatory Affairs, specifically within PRC/MLR review operations.
• Strong working knowledge of Veeva Vault, including digital asset submission, routing, and tracking.
• Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams.
• Experience working with agencies and internal content teams to resolve feedback and ensure compliance.
• Operational mindset with the ability to streamline processes, identify gaps, and implement best practices.
• Prior experience in training and documentation development is a plus.
• Familiarity with AI applications in regulatory or marketing contexts is a bonus.
Required Years of Experience: 6-8 years
Top 3 Required Skill Sets:
a. Experience in Medical, Legal, and Regulatory (MLR) review process
b. Proficiency in Veeva Vault PromoMats
c. Project Management and workflow optimization
Top 3 Nice to Have Skill Sets:
a. Documentation and process mindset
b. Change Management
c. Familiarity with AI
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4
Regulatory Affairs Manager
28645 Lenoir, North Carolina
ClinLab Staffing
Posted today
Job Viewed
Job Description
Regulatory Affairs Manager - Biologics
Job Purpose
** MUST HAVE BIOLOGICS EXPERIENCE **
LOCATION: On-site in Lenoir, NC
** Will assist in relocation **
The Americas Regulatory Affairs Manager is responsible for overseeing and managing the routine operations of the regulatory affairs department. In this role, the Manager ensures compliance with applicable regulatory requirements, including those from the US FDA, Health Canada, USDA, and other applicable regulatory agencies, while providing regulatory strategy and support across the business.
Major Accountabilities
- Oversee and manage all Regulatory Affairs activities to ensure the technical accuracy, quality, content and format of all regulatory submissions in the appropriate format (eCTD) to the FDA, Health Canada, USDA, and other regulatory agencies.
- Lead the preparation, submission and management of regulatory filings such as INDs, BLAs, 510(k)s and/or other market authorization applications for both existing and new products.
- Assess and address regulatory impact of product and manufacturing changes, including overseeing change control assessments.
- Plan, coordinate and participate in formal meetings, teleconferences, and written communication with regulatory agencies, ensuring timely responses to requests.
- Oversee the preparation, review, and submission of all biologic and veterinary prescribing information and product labeling, ensuring compliance with all regulatory requirements.
- Review and approve promotional and advertising materials, ensuring adherence to applicable laws, regulations, and company policies, including timely submission of materials to regulatory agencies.
- Provide regulatory strategy guidance to project teams and other departments to support product development and life cycle management.
Professional Experience/Qualifications
- 5+ years of related regulatory experience in the biologics and medical device areas.
- Regulatory Affairs Certification (RAC) is preferred.
- Thorough understanding of the laws and regulations for the US FDA, Health Canada, USDA, ICH Guidelines, and any other applicable Agency.
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5
Regulatory Affairs Manager
28645 Lenoir, North Carolina
EPM Scientific
Posted today
Job Viewed
Job Description
Overview:
A growing biopharmaceutical company is seeking a Regulatory Affairs Manager to lead strategic regulatory operations across the U.S., Canada, and other global markets. This is a high-impact leadership role responsible for overseeing regulatory submissions, compliance, and strategy for biologics and medical devices.
Key Responsibilities:
- Lead preparation and submission of regulatory filings (INDs, BLAs, 510(k)s, etc.) in eCTD format
- Manage communications with regulatory agencies including FDA, Health Canada, and USDA
- Oversee promotional and advertising material review and submission
- Provide regulatory guidance on product development and lifecycle management
- Collaborate cross-functionally with Quality, R&D, Manufacturing, and Commercial teams
- Monitor regulatory changes and ensure ongoing compliance
- Lead and mentor the regulatory team, driving performance and professional growth
- Support budgeting and resource planning for the regulatory department
Qualifications:
- 5+ years of regulatory affairs experience in biologics and/or medical devices
- Strong knowledge of FDA, Health Canada, USDA regulations
- Experience with eCTD submissions and promotional review
- Proven leadership and team management experience
- RAC certification preferred
- Bachelor's degree in a scientific discipline required
Why Apply?
This is an opportunity to make a direct impact on regulatory strategy and product success within a mission-driven organization focused on improving patient outcomes through innovative immunotherapy solutions.
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