102 Pharmaceutical Company jobs in Rahway

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

About the Role

The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting commercial product lifecycle management, and providing backup to the Director of Regulatory Affairs. The role plays an essential part in ensuring timely, compliant regulatory filings and strategic input for product development, with particular focus on complex generics and combination products. This role also includes supporting GDUFA III-related meeting package preparation.

Responsibilities

• Compile and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements.
• Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata.
• Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission planning and execution.
• Support regulatory strategy and submissions for complex generics and combination products (e.g., transdermal systems, injectables, drug-device combinations).
• Create and maintain internal templates, trackers, and tools to manage regulatory planning and combination product submissions.
• Provide regulatory support for Design History Files (DHFs), ensuring consistency and alignment with FDA expectations for device related documentation.
• Prepare formal meeting packages and briefing documents under GDUFA III, including pre-submission and mid-cycle meetings.
• Coordinate with internal departments and external partners for documentation collection, timeline management, and regulatory compliance.
• Represent Regulatory Affairs in internal cross-functional meetings and external partner calls, as needed.
• Lead regulatory activities for post-approval changes including site transfers, analytical method updates, container/closure system changes, and alternative sourcing of materials.
• Participate in product development from early-stage formulation to final submission, incorporating FDA feedback and seeking regulatory guidance when appropriate.
• Draft, review, and maintain product labeling and promotional labeling, ensuring alignment with current regulations and internal policies.
• Review technical documentation and provide regulatory guidance to internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design (QbD) principles.
• Ensure submission documentation is accurate, complete, and in compliance with applicable FDA regulations and company quality standards.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field required.
• Advanced degree preferred.

Required Skills

• 5+ years’ experience in pharmaceutical regulatory affairs.
• Experience with complex and combination products and knowledge of FDA expectations.
• Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software.
• Independently compiled and filed ANDAs
• Familiar with cGMP requirements.
• Sterile products experience

Compensation & Benefits

At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off programs
• Competitive compensation packages
• The anticipated annual salary for this role is $88,000-125,000

Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Career Programs

Job Sub Function:

Non-LDP Intern/Co-Op

Job Category:

Career Program

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America

Job Description:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

We are searching for the best talent in Regulatory Affairs.

This position is on site on our Cincinnati, OH campus.

Regulatory affairs professionals support the development, testing, manufacturing and marketing of healthcare products to provide the safest, most effective and highest-quality medical devices, pharmaceuticals, biologics, diagnostics, and digital health for patients and the public at-large. A trained Regulatory Affairs Specialist provides regulatory guidance to project teams in strategic planning and related submissions to support Johnson & Johnson products.

In this role the co-op associate will be exposed to practices to develop and execute regulatory strategy for new products and significant changes for the US and Global markets, to support product launches and continued commercialization of products in key countries. The co-op may create processes to helps define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures and systems.

Key Duties may include:

• Ensures compliance with regulatory agency regulations and interpretations.
• Assist with the preparation for responses to regulatory agencies' questions and other correspondence.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
• Support internal and external audit activities
• Research and assist in the development of best practices for Regulatory Affairs processes, ultimlately leading to expedited product to the patient, nurses and surgeons
• Represent Regulatory Affairs throughout the business including cross-functional project teams

Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.

Ineligibility for Severance.

The expected pay range for this position is between $23.00 per hour and $1.50 per hour but will be based on candidate's program year, discipline, degree and/or experience. Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).

For additional general information on Company benefits, please go to:

This job posting is anticipated to close on 10/17/2025. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.

#LI-Onsite

The anticipated base pay range for this position is :

$23. 0/hr to 51.50/hr

Additional Description for Pay Transparency:

The expected pay range for this position is between 23.00 per hour and 51.50 per hour but will be based on candidate's program year, discipline, degree and/or experience. Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension). For additional general information on Company benefits, please go to: This job posting is anticipated to close on 1/12/2026. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

About the Role

The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting commercial product lifecycle management, and providing backup to the Director of Regulatory Affairs. The role plays an essential part in ensuring timely, compliant regulatory filings and strategic input for product development, with particular focus on complex generics and combination products. This role also includes supporting GDUFA III-related meeting package preparation.

Responsibilities

• Compile and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements.
• Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata.
• Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission planning and execution.
• Support regulatory strategy and submissions for complex generics and combination products (e.g., transdermal systems, injectables, drug-device combinations).
• Create and maintain internal templates, trackers, and tools to manage regulatory planning and combination product submissions.
• Provide regulatory support for Design History Files (DHFs), ensuring consistency and alignment with FDA expectations for device related documentation.
• Prepare formal meeting packages and briefing documents under GDUFA III, including pre-submission and mid-cycle meetings.
• Coordinate with internal departments and external partners for documentation collection, timeline management, and regulatory compliance.
• Represent Regulatory Affairs in internal cross-functional meetings and external partner calls, as needed.
• Lead regulatory activities for post-approval changes including site transfers, analytical method updates, container/closure system changes, and alternative sourcing of materials.
• Participate in product development from early-stage formulation to final submission, incorporating FDA feedback and seeking regulatory guidance when appropriate.
• Draft, review, and maintain product labeling and promotional labeling, ensuring alignment with current regulations and internal policies.
• Review technical documentation and provide regulatory guidance to internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design (QbD) principles.
• Ensure submission documentation is accurate, complete, and in compliance with applicable FDA regulations and company quality standards.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field required.
• Advanced degree preferred.

Required Skills

• 5+ years’ experience in pharmaceutical regulatory affairs.
• Experience with complex and combination products and knowledge of FDA expectations.
• Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software.
• Independently compiled and filed ANDAs
• Familiar with cGMP requirements.
• Sterile products experience

Compensation & Benefits

At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off programs
• Competitive compensation packages
• The anticipated annual salary for this role is $88,000-125,000

Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Major pharmaceutical company is recruiting a candidate with a nursing background to call on hospitals in the Bronx and surrounding areas. Must have a nursing degree and be able to present clinically at the hospital level. Compensation includes a base salary: $100-$50 + 50- 100k commission + company car or car allowance + excellent medical benefits, eye care, dental, 401k and stock option savings plan. If interested in learning more, please forward your resume to:

About Ascendia Pharmaceutical Solutions:

Ascendia is a Contract Development and Manufacturing Organization (CDMO) company dedicated to enabling formulations for pre-clinical and clinical stage drug candidates and developing enhanced formulations of existing drug products. Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies. Ascendia assesses the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability and solubility. Ascendia’s technologies include nano-emulsions, amorphous solid dispersions, nano-milling, injectable, lipid nanoparticles, and oral controlled release. Ascendia provides development, manufacturing and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.

The mission of our company is to provide customized formulation solutions to “salvage” difficult compounds and to create advanced medicines to help patients “prevail” over their disease and enhance quality of life.

About the Position:

Job Summary:

We are looking for a highly skilled and detail-oriented Pharmaceutical Project Manager to support the management and execution of pharmaceutical R&D and cGMP drug product manufacturing projects. In this role, you will assist in creating and updating project timelines, manage agendas and meeting minutes, source necessary resources and materials, and track the progress of project deliverables. The ideal candidate will be proactive and have excellent organizational skills, attention to detail, and experience in project management within the pharmaceutical or healthcare sectors.

Key Responsibilities:

• Project Coordination:
• Assist with the creation and management of detailed project timelines, tracking milestones, and ensuring all deliverables are completed on time.
• Meeting Management:
• Coordinate project meetings, prepare agendas, ensure relevant stakeholders are invited, and take clear and concise meeting minutes. Follow up on action items to ensure timely completion.
• Sourcing & Vendor Management:
• Support the sourcing of materials, vendors, and other resources required for the project. Work with cross-functional teams to ensure the timely procurement of required resources.
• Documentation & Reporting:
• Ensure that all project documentation is up-to-date and easily accessible. Track and report on the status of project deliverables, including any potential risks or delays.
• Stakeholder Communication:
• Communicate regularly with internal and external stakeholders to provide updates on project status, resolve issues, and ensure alignment on project goals and timelines.
• Quality Control:
• Monitor the project’s progress and performance, identifying and addressing any gaps or issues. Ensure all activities are compliant with industry regulations and quality standards.
• Process Improvement:
• Identify opportunities for process improvements and work with the team to implement more efficient project management strategies.
• Business Development

Ensure timely generation of scopes of work from existing clients garnering feedback from relevant stakeholders.

Qualifications:

• Education:
• Bachelor’s degree in Pharmaceutical Sciences, Business, Project Management, or a related scientific field. PMP certification or equivalent is a plus.
• Experience:
• 1-3+ years of experience in pharmaceutical project management or a similar role, with proven ability to manage cross-functional teams and multiple projects simultaneously.
• Skills:
• Knowledge of pharmaceutical industry regulations and standards is strongly preferred. Project management experience in a CDMO environment is a plus.
• Strong organizational and time-management skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and project management tools (e.g., MS Project, Trello, Asana).
• Excellent written and verbal communication skills.
• Ability to work independently and handle multiple tasks simultaneously.
• Strong attention to detail and problem-solving abilities.

Under the supervision of the Assistant General Counsel (ACG), review prepare and negotiate a full range of hospital contracts including, without limitation, physician contracts, IT, SaaS and software licensing agreements, clinical affiliation agreements, transfer agreements, Human Resource search and staffing agreements, procurement of goods and services, leases of space and equipment, event contracts, confidentiality and consulting agreements, transport and ambulance agreements, and home health and hospice agreements, assuring legal and regulatory compliance. Serve as a primary resource for the interpretation of contractual obligations, benefits and remedies. This position is onsite and located in Morristown, NJ .

-Working with Contract Coordinators, oversee physician, real estate and contract management process, including development of electronic databases. Assume primary responsibility for physician contract compliance.

-Assist the General Counsel and Assistant General Counsel on major transactions, including mergers, acquisitions, affiliations and joint ventures, serving as a resource for the management of the due diligence process.

-Serve as a key subject matter resource on healthcare laws and regulations, including, without limitation, monitoring of regulatory developments, and legal research on regulatory issues, including fraud and abuse issues, HIPAA compliance, EMTALA, Medicare and Medicaid compliance, licensure issues, pay-to-play issues, corporate governance and regulatory issues related to tax-exempt entities.

-As required, participate in the development, review and revision of clinical and corporate policies. Review and prepare informed consents, appearance releases, consents to videotaping, etc.

-As requested, serve as legal advisor to various committees, work groups and task forces. Work collaboratively with Risk Management, Insurance, Privacy, Audit & Compliance and other key functional areas to align efforts, improve decision-making, reduce risks and improve quality outcomes.

-People: Creates a working environment that promotes positive employee engagement, adherence to company policies, effective communications, collaboration, innovation, optimal productivity and continuous learning. Assures that systems are in place to ensure appropriate resources and competent staff.

-Service: Focuses staff on continuously building customer satisfaction for patients, physicians, colleagues, the community and other departments served. Engages staff in continually raising the bar in service excellence.

-Growth: Communicates effectively as hospital/system advocate to members of the community, continually seeks ways to promote organization to the public.

-Quality: Assures the implementation of standards of professional practice occurs, reviews and revises documents according to policy or as necessary to reflect changes in practice and to ensure safe, effective and efficient patient care. Develops, with our physician colleagues, a system-wide quality review program. Ensures compliance with local, state, federal rules and regulations and OSHA and The Joint Commission standards.* Consistently, with others, evaluates core processes for redesign opportunities to improve operations, reduce cost, reduce cycle time, enhance service and improve performance.

Qualifications/Requirements:

Ability to work independently and serve as lead attorney on matters

Excellent analytical and writing skills

Ability to identify and resolve regulatory issues

A particular strength in physician contracting, including practice acquisitions, vendors and corporate services contracting, and familiarity with IT contracting

Strong customer orientation with an ability to accommodate a high volume of diverse requests and to interact with team members at all levels of the organization

Minimum Education:

JD from an ABA-approved law school and be an active member in good standing of the New Jersey Bar required

Relevant Experience:

5+ years of relevant healthcare law experience; law firm experience required

Healthcare regulatory and corporate work experience, including prior experience with hospitals, Medicare and Medicaid, and federal and state healthcare regulatory issues, including fraud and abuse, the Stark Law, the Anti - Kickback Statute, HIPAA/HITECH and NJDPA

Experience working with SaaS agreements and other technology agreements

bout Us

At Atlantic Health System, our promise to our communities is; Anyone who enters one of our facilities, will receive the highest quality care delivered at the right time, at the right place, and at the right cost. This commitment is also echoed in the respect, development and opportunities we give to our more than 20,000 team members. Headquartered in Morristown, New Jersey, we are one of the leading non-profit health care systems in the nation. Our facilities and sites of care include:

• Morristown Medical Center, Morristown, NJ
• Overlook Medical Center, Summit, NJ
• Newton Medical Center, Newton, NJ
• Chilton Medical Center, Pompton Plains, NJ
• Hackettstown Medical Center, Hackettstown, NJ
• Goryeb Children's Hospital, Morristown, NJ
• CentraState Healthcare System, Freehold, NJ
• Atlantic Home Care and Hospice
• Atlantic Mobile Health
• Atlantic Rehabilitation

We also have more than 900 community-based healthcare providers affiliated through Atlantic Medical Group. Atlantic Accountable Care Organization is one of the largest ACOs in the nation, and we are a member of AllSpire Health Partners.

We have received awards and recognition for the services we have provided to our patients, team members and communities. Below are just a few of our accolades:

• 100 Best Companies to Work For ® and FORTUNE® magazine for 15 years
• Best Places to Work in Healthcare - Modern Healthcare
• 150 Top Places to work in Healthcare - Becker's Healthcare
• 100 Accountable Care Organizations to Know - Becker's Hospital Review
• Best Employers for Workers over 50 - AARP
• Gold-Level "Well Workplace": Wellness Council of America (WELCOA)
• One of the 100 Best Workplaces for “Millennials” Great Place to Work® and FORTUNE® magazine
• One of the 20 Best Workplaces in Health Care: Great Place to Work® and FORTUNE® magazine
• Official Health Care Partner of the New York Jets
• NJ Sustainable Business

Atlantic Health System offers a competitive and comprehensive Total Rewards package that supports the health, financial security, and well-being of all team members. Offerings vary based on role level (Team Member, Director, Executive). Below is a general summary, with role-specific enhancements highlighted:

Team Member Benefits

• Medical, Dental, Vision, Prescription Coverage (22.5 hours per week or above for full-time and part-time team members)
• Life & AD&D Insurance.
• Short-Term and Long-Term Disability (with options to supplement)
• 403(b) Retirement Plan: Employer match, additional non-elective contribution
• PTO & Paid Sick Leave
• Tuition Assistance, Advancement & Academic Advising
• Parental, Adoption, Surrogacy Leave
• Backup and On-Site Childcare
• Well-Being Rewards
• Employee Assistance Program (EAP)
• Fertility Benefits, Healthy Pregnancy Program
• Flexible Spending & Commuter Accounts
• Pet, Home & Auto, Identity Theft and Legal Insurance

___

Note: In Compliance with the NJ Pay Transparency Act (effective Sunday, June 1, 2025), all job postings will include the hourly wage or salary (or a range), as well as this summary of benefits. Final compensation and benefit eligibility may vary by role and employment status and will be confirmed at the time of offer.

EEO STATEMENT

Atlantic Health System, Inc. is an equal employment opportunity employer and federal contractor or subcontractor and therefore abides by applicable laws to protect applicants and employees from discrimination in hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral, and other aspects of employment, on the basis of race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, citizenship status, disability, age, genetics, or veteran status.

About the Team

Atlantic Health System is at the forefront of medicine, setting standards for quality health care powered by a workforce of more than 18,000 team members and 4,800 affiliated physicians dedicated to building healthier communities, the system offers more than 400 sites of care, including eight award-winning medical centers. Specializing in cardiovascular care, cancer care, orthopedics, neuroscience, pediatrics, women's health and rehabilitation medicine. Atlantic Medical Group, comprised of 1,000 physicians and advanced practice providers, represents one of the largest multi-specialty practices in New Jersey and includes finance, legal, marketing, human resources, talent acquisition, ISS and more. Caring for our patients, our team members and the communities we serve is our central mission.

Apply Now

Job Info

• Job Identification18049
• Job CategoryLegal/Comp/RiskMgmt/GovAffairs
• Posting Date04/22/2025, 12:05 PM
• Job ScheduleFull-Time
• Locations 475 South Street, Morristown, NJ, 07960, US
• Minimum Salary (Hourly Rate)
• Maximum Salary (Hourly Rate)
• Assignment CategoryFull-time
• Hours per Week37.5
• Primary ShiftDay
• Work Schedule8 am - 4 pm
• Days and ShiftsM-F 8am to 4pm
• Department - Legal Internal Audit - Legal Svcs
• DivisionCorporate
• SpecialtyOther
• Service LineOther
• RegionCorporate
• Salary Admin PlanMGR
• Overtime StatusExempt