Head of Regulatory Affairs

16 hours ago


Bridgewater NJ USA, United States Actalent Full time
Job Title:Head of Regulatory Affairs

We are seeking a seasoned regulatory affairs professional to lead our regulatory submissions and develop our company's regulatory strategy.

This role will oversee the regulatory affairs and operations team, partnering closely with R&D, Technical Operations, and clinical development teams to advance our portfolio and ensure commercial success.

The successful candidate will have a strong track record of regulatory leadership, with experience in negotiating, filing, and obtaining approved registration with the FDA and Ex-US Regulatory Authorities.

Key responsibilities include:

  • Developing and implementing regulatory strategies for product development
  • Corresponding with global regulatory agencies, including the FDA, EU, and China
  • Leading the regulatory affairs and operations team
  • Partnering with R&D, Technical Operations, and clinical development teams

The ideal candidate will have a minimum of 10-15 years of regulatory affairs experience, with a strong understanding of drug development, including R&D, CMC/manufacturing upscaling, preclinical, and clinical requirements.

Pre-established relationships with the FDA and other regulatory agencies are a plus.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people.

We embed DE&I into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes

We are an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.



  • Bridgewater, NJ , USA, United States Actalent Full time

    Job Title: Head of Regulatory AffairsWe are seeking a highly skilled and experienced Head of Regulatory Affairs to join our team at Actalent. As a key member of our management and product development leadership teams, you will play a critical role in advancing our company's portfolio and ensuring commercial success.Key Responsibilities:Lead our regulatory...


  • US-, Bridgewater, NJ , USA Actalent Full time

    Job Title: Head of Regulatory AffairsActalent is seeking a seasoned regulatory affairs professional to lead our regulatory submissions and strategy. As a key member of our management team, you will be responsible for guiding the strategic direction of our development programs and ensuring they meet regulatory approval standards.Key Responsibilities:Lead...


  • Bridgewater, NJ , USA, United States Proclinical Staffing Full time

    Associate Director, Regulatory Affairs, Advertising & PromotionProclinical Staffing is seeking an experienced Associate Director, Regulatory Affairs, Advertising & Promotion to join a global pharmaceutical company in New Jersey.Key Responsibilities:Review and approve prescription drug product advertising and promotional labeling pieces for compliance with...


  • Bridgewater, New Jersey, United States Proclinical Staffing Full time

    Associate Director, Regulatory Affairs, Advertising & PromotionProclinical is seeking an experienced Associate Director, Regulatory Affairs, Advertising & Promotion to join a global pharmaceutical company in New Jersey.Key Responsibilities:Review and approve prescription drug product advertising and promotional labeling pieces for compliance with regulatory...


  • Bridgewater, New Jersey, United States EUSA Pharma Full time

    Job Title: Senior Manager, Regulatory AffairsThis is a challenging opportunity to join our team at Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.We are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to lead our Regulatory Affairs Lifecycle Management team. The successful candidate will be...


  • US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Senior Manager, Regulatory AffairsSun 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, supporting the Global RA submission process and...


  • Carlsbad, CA, USA, United States Ionis Full time

    Director of Regulatory AffairsIonis Pharmaceuticals, a pioneering company in RNA-targeted medicines, is seeking a seasoned Director of Regulatory Affairs to lead the commercial regulatory strategy for our first-ever wholly owned commercial program. As a key member of our Regulatory Affairs team, you will be responsible for formulating and implementing...


  • Carlsbad, CA, USA, United States Ionis Full time

    Director of Regulatory AffairsIonis Pharmaceuticals, a pioneer in RNA-targeted medicines, seeks a seasoned Director of Regulatory Affairs to lead the commercial regulatory strategy for our first-ever wholly owned commercial program. As a key member of our Regulatory Affairs team, you will be responsible for formulating and implementing creative and robust...


  • Massachusetts, USA, United States EPM Scientific Full time

    Director of Regulatory AffairsEPM Scientific is seeking a seasoned Director of Regulatory Affairs to drive our gene editing company's groundbreaking projects through the complex regulatory landscape with vision and precision.This pivotal role will harness your strategic acumen and hands-on expertise to navigate regulatory requirements and lead critical...


  • Trenton, NJ, 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 Company Match on...


  • California, USA, United States Planet Pharma Full time

    Job Title: Regulatory Affairs Associate Director/DirectorPlanet Pharma is seeking a highly skilled Regulatory Affairs Associate Director/Director to join our team in South San Francisco, CA. This is a 6-month contract opportunity.Key Responsibilities:Develop and implement competitive and effective global regulatory strategies for oncology products, including...


  • Princeton, NJ, 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...


  • Gaithersburg, MD , USA, United States Proclinical Staffing Full time

    Director, Global Regulatory Affairs, Development StrategyProclinical is seeking a seasoned professional to lead our client's global regulatory affairs and development strategy efforts.Key Responsibilities:Develop and implement a comprehensive US regulatory development strategy to ensure successful registration and life-cycle management of complex...


  • US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Regulatory Affairs Strategy Senior Director OpportunitySun Pharmaceutical Industries, Inc. is seeking a highly experienced Senior Director to lead our Regulatory Affairs Strategy team. As a key member of our global regulatory affairs team, you will be responsible for developing and executing the overall regulatory strategy for our novel drug development...


  • California, USA, United States Bow and Arrow Holdings, LLC Full time

    Job Title: Director of Regulatory AffairsWe are seeking an experienced Director of Regulatory Affairs to join our team at Bow and Arrow Holdings, LLC. As a key member of our organization, you will be responsible for developing and executing advocacy strategies that support distributed generation development on residential real estate in our target...


  • Gaithersburg, MD , USA, United States Proclinical Staffing Full time

    Job Title: Director, Global Regulatory Affairs, Development StrategyProclinical Staffing is seeking a highly skilled Director, Global Regulatory Affairs, Development Strategy to join our team. As a key member of our organization, you will be responsible for developing and implementing US regulatory development strategies to ensure successful registration and...


  • Miami, FL , USA, United States Public Health Trust of Dade Co Full time

    Job SummaryThe Assistant Director of Regulatory Affairs is a key member of the leadership team responsible for ensuring the organization's compliance with regulatory standards and hospital licensure requirements. This role involves overseeing the organization-wide oversight and resolution of regulatory and hospital licensure matters, including process...


  • Miami, FL , USA, United States Public Health Trust of Dade Co Full time

    Job SummaryThe Assistant Director of Regulatory Affairs is a key member of the leadership team responsible for ensuring the organization's compliance with regulatory standards and hospital licensure requirements. This role involves overseeing the organization-wide oversight and resolution of regulatory and hospital licensure matters, including process...


  • Washington, DC , USA, United States Exelon Corporation Full time

    Job Title: Regulatory Affairs DirectorExelon Corporation is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies that drive business growth and profitability.Key Responsibilities:Develop and manage regulatory relationships...


  • HOPEWELL, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...