Current jobs related to Sr. Director, Regulatory Affairs Strategy - Princeton - Sun Pharmaceutical Industries, Inc.

  • Sr. Director, Regulatory Affairs Strategy

    3 months ago

    Princeton, United States Sun Pharma (Taro Pharma) 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...

  • Sr. Director, Regulatory Affairs Strategy

    4 weeks ago

    Princeton, 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...

  • Sr. Director, Regulatory Affairs Strategy

    3 months ago

    PRINCETON, United States Sun Pharma (Taro Pharma) 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...

  • Sr. Director, Regulatory Affairs Strategy

    3 months ago

    Princeton, United States Sun Pharma (Taro Pharma) 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...

  • Director Regulatory Affairs Strategy

    3 months ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    3 months ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Sr. Director, Regulatory Affairs Strategy

    3 months ago

    Princeton, NJ, United States Sun Pharma (Taro Pharma) 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...

  • Director, Regulatory Affairs Strategy

    3 weeks ago

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

    The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

  • Director, Regulatory Affairs Strategy

    7 days ago

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

    The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

  • Director, Regulatory Affairs Strategy

    1 week ago

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

    The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

  • Director, Regulatory Affairs Strategy

    4 weeks ago

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

    The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

  • Director - Regulatory Affairs - CMC & Compliance

    1 month ago

    Princeton, New Jersey, United States Novo Nordisk Full time

    About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product...

  • Regulatory Affairs Director

    2 days ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job SummaryThe Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This role will provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.Key ResponsibilitiesServe as key corporate regulatory...

  • Director, Regulatory Affairs Strategy

    3 weeks ago

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

    The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

  • Director Regulatory Affairs

    3 months ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and...

  • Manager - Regulatory Affairs - Therapeutic Area

    1 month ago

    Princeton, New Jersey, United States Novo Nordisk Full time

    About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product...

  • Director, Medical Affairs

    2 months ago

    Princeton, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive,...

  • Regulatory Affairs Manager

    1 month ago

    Princeton, United States MRINetwork Jobs Full time

    Job DescriptionJob DescriptionA growing organization in the Pharmaceutical industry is in need of a Regulatory Affairs Manager based in the greater Princeton NJ area. This role is responsible for preparing and reviewing a variety of regulatory submissions to the appropriate agencies. The Manager will collaborate closely with the Director and VP of Regulatory...

  • Head of Regulatory Affairs CMC

    7 days ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Position OverviewOur esteemed client in the pharmaceutical sector is in search of a Director of Regulatory Affairs for Chemistry Manufacturing & Controls (CMC). This role is pivotal in steering global teams through the intricacies of regulatory strategy and the formulation of CMC elements within drug development initiatives. Collaboration with various...

  • Regulatory Affairs Manager

    1 month 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...

Sr. Director, Regulatory Affairs Strategy

2 months ago

Princeton, United States Sun Pharmaceutical Industries, Inc. Full time
Senior Director, Global Regulatory Affairs Strategy

The Senior Director, Global Regulatory Affairs Strategy will provide strategic leadership in regulatory affairs for our company and its innovative drug development programs.

  • Develop and implement regulatory strategies for new drug programs
  • Ensure compliance with ICH and local regulatory requirements
  • Strong project management and interpersonal skills for managing complex programs
  • Author clear regulatory documents and oversee submissions
  • Collaborate with regulatory CMC lead and development team for alignment
  • Act as the regulatory liaison between the company and regulatory agencies
Qualifications
  • Master's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering required; PhD or PharmD preferred
  • Minimum of 10 years industry experience in regulatory affairs for new drug development
  • Experience with CMC and/or Botanicals, RAC certification
  • Proficiency in ICH and US CFR regulations
  • Expertise in authoring regulatory documents and interacting with regulatory agencies
  • Excellent communication skills