Current jobs related to Regulatory Affairs Manager - Princeton - The Dunwoody Group

  • Regulatory Affairs Manager

    1 week ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job Title: Regulatory Affairs ManagerJob Summary: We are seeking a highly skilled Regulatory Affairs Manager to join our team at TK-CHAIN LLC. The successful candidate will be responsible for managing regulatory activities associated with planning, authoring, compiling, and submitting high-quality regulatory submissions to the FDA within company timelines...

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Our Team as a Senior Manager, Regulatory AffairsSun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company, and we are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of...

  • Regulatory Affairs Senior Manager

    4 days ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Unlock Your Potential in Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of regulatory documents to health authorities worldwide.Key...

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About UsSun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company that delivers high-quality, affordable medicines to patients worldwide.Job SummaryWe are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. The successful candidate will be responsible for publishing and coordinating tasks for Global RA...

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Manager, Regulatory AffairsJoin Sun Pharmaceutical Industries, Inc. as a Senior Manager, Regulatory Affairs and be part of a team that is dedicated to making good health accessible and affordable to local communities and society at large.About the RoleThe Senior Manager, Regulatory Affairs will be responsible for publishing and coordinating tasks for...

  • Senior Manager Regulatory Affairs

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job OverviewSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will be responsible for publishing and coordinating tasks for Global RA submission activities.Key Responsibilities:Coordinate and manage various programs and projects...

  • Regulatory Affairs Specialist

    4 days ago

    Princeton, New Jersey, United States Avance Consulting Full time

    Job Title: Regulatory Affairs ManagerJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to support our client in the preparation and submission of Clinical Trial Applications (CTAs) within the EU Clinical Trial Regulation (CTR) framework.Key Responsibilities:* Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS)...

  • Senior Regulatory Affairs Manager

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Our Team at Sun Pharmaceutical Industries, Inc.We are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team at Sun Pharmaceutical Industries, Inc. This is an exciting opportunity to work with a global leader in the pharmaceutical industry.About the RoleThe Senior Manager, Regulatory Affairs will be responsible for handling...

  • Regulatory Affairs Director

    2 weeks ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job SummaryThe Director of Regulatory Affairs will play a key role in ensuring the compliance of our clients' drug development programs with US regulatory guidelines and federal regulations. This individual will be responsible for integrating and applying knowledge of regulatory guidelines and federal regulations to all aspects of our clients' drug...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States Genmab AS Full time

    Job Title: Regulatory Affairs DirectorGenmab is seeking an experienced Regulatory Affairs Director to join our Global Regulatory Affairs organization. As a key member of our team, you will be responsible for developing and implementing global and US regulatory strategies to advance our portfolio of development pipeline candidate drugs.Key...

  • Senior Manager Regulatory Affairs Professional

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job OverviewSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for publishing and coordinating tasks for Global RA submission activities.Key Responsibilities:Coordinate and manage various programs and projects for...

  • Regulatory Affairs Director

    2 weeks ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Director, Regulatory Strategy is a key member of the Global Regulatory Affairs team, responsible for providing strategic direction and guidance on regulatory matters for assigned brand programs. This role requires a deep understanding of regulatory requirements and a strong ability to communicate effectively with cross-functional teams.Key...

  • Senior Manager, Regulatory Affairs Specialist

    1 week ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Sun Pharmaceutical Industries, Inc. as a key member of our Regulatory Affairs team!We are seeking a highly skilled Senior Manager, Regulatory Affairs to handle publishing and coordinating tasks for Global RA submission activities. This role will support the Global RA submission process and infrastructure.Must be able to multi-task and coordinate for...

  • Senior Manager, Regulatory Affairs

    4 months ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug Coverage Telehealth and Behavior Health Services Income Protection – Short Term and Long Term Disability Benefits Retirement Benefits - 401k Company Match on...

  • Senior Manager, Regulatory Affairs

    1 month ago

    PRINCETON, United States Sun Pharmaceutical Industries, Inc. Full time

    p>COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Hybrid work arrangement * Medical, Dental, Vision Benefits * Health Savings Account (HSA), Flexible Spending Account (FSA) * Prescription Drug Coverage * Telehealth and Behavior Health Services * Income Protection - Short Term and Long Term Disability Benefits * Retirement Benefits - 401k...

  • Senior Manager, Regulatory Affairs

    4 days ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day One...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job Title: Director, Global Regulatory LeadThe Director, Global Regulatory Lead is a key member of the regulatory team, responsible for ensuring compliance with regulatory requirements and guidelines. This role requires a strong understanding of regulatory affairs and the ability to communicate effectively with cross-functional teams.Key...

  • Director of Regulatory Affairs Strategy

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide strategic leadership for the company's regulatory affairs and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and...

  • Regulatory Affairs Director

    1 week ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job SummaryThe Director, Regulatory Strategy is responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.Key ResponsibilitiesDevelop and execute regulatory strategies...

Regulatory Affairs Manager

3 months ago

Princeton, United States The Dunwoody Group Full time

A growing pharmaceutical company based in the greater Princeton NJ area is looking for a Regulatory Affairs Manager


This role is responsible for assisting the company with regulatory strategies to ensure compliance with governing agencies, including the documentation, review and tracking of regulatory submissions. The ideal person will have a technical understanding of topical products with experience filling ANDAs.

Requirements:

-Bachelor's degree in science, chemistry, pharmacology or related

-5+ years regulatory affairs experience in FDA regulated pharmaceutical industry

-knowledge of U.S. regulatory submission policies, as well as related governmental regulations (FDA, OSHA, GMP, etc.)

-experience reviewing laboratory and manufacturing investigations