2,739 Regulatory jobs in the United States

Regulatory Associate/Regulatory Affairs Associate/Regulatory Specialist

Il, Illinois Actalent

Posted 3 days ago

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Job Description

Lab Technician

The quality technician supports production by conducting tests on all incoming materials, processes, and outgoing products, as well as performing environmental testing. This position is for the 2nd shift, Thursday through Sunday, from 1:00 PM to 11:30 PM.

Responsibilities
  • Perform bacterial plating and microbiology tests.
  • Conduct pH testing and use infrared readers for butter fat and total solids analysis.
  • Execute titratable acidity tests and calibrate machines.
  • Perform weight checks and various lab tests to determine chemical and physical characteristics or components of ingredients, in-process samples, and finished products.
  • Ensure all test results meet cGMP/FDA specifications.
  • Assist the R&D team in formulating new products occasionally.
  • Record test results on standard forms and write detailed test reports.
  • Clean, sterilize, and calibrate all lab equipment.
  • Follow all SOPs and adhere to GMP/FDA regulations.
Essential Skills
  • Proficiency in chemistry, biology, and wet chemistry.
  • Experience with titration, microbiology, and quality control.
  • Understanding of GMP regulations and laboratory procedures.
Additional Skills & Qualifications
  • Bachelor's or Associate's degree with lab experience in Biology or a related field is preferred.
  • High school diploma with industry experience in a lab will be considered.
  • Aseptic technique is desired but not mandatory.
  • Quick learning ability, interpersonal skills, and multitasking capabilities.
  • Experience in the restaurant industry is advantageous.
  • Ability to taste products; candidates should not be lactose intolerant.

The work environment includes both lab and manufacturing settings, where adherence to safety protocols and attention to detail are crucial.

This is a Contract to Hire position based out of Pacific, Missouri.

The pay range for this position is $21.60 - $21.60/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in East St. Louis, IL.

This position is anticipated to close on Sep 30, 2025.

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Intern - Regulatory Affairs

21214 Baltimore, Maryland Labcorp

Posted today

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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, 2026 - 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. Additionally, 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

Intern - Regulatory Affairs

21276 Baltimore, Maryland Labcorp

Posted today

Job Viewed

Tap Again To Close

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
View Now

Intern - Regulatory Affairs

21276 Baltimore, Maryland Labcorp

Posted today

Job Viewed

Tap Again To Close

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
View Now

Regulatory Affairs Specialist

New
19488 Norristown, Pennsylvania Jacobs Management Group, Inc.

Posted today

Job Viewed

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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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Regulatory Affairs Manager

New
94420 Foster City, California ACL Digital

Posted today

Job Viewed

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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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Regulatory Affairs Manager

New
28645 Lenoir, North Carolina EPM Scientific

Posted today

Job Viewed

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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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