Senior Director, Global Regulatory Portfolio Lead

2 days ago


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

We are seeking a highly experienced Senior Director to lead our Global Regulatory Portfolio team. As a key member of our Global Regulatory Affairs Leadership Team, you will be responsible for providing strategic direction and guidance on regulatory strategy for our in-line and pipeline assets.

Key Responsibilities
  • Develop and execute regulatory strategies for assigned programs
  • Provide leadership and guidance to a team of regulatory professionals
  • Collaborate with cross-functional teams to ensure regulatory compliance
  • Stay up-to-date with regulatory agency regulations and guidelines
  • Communicate effectively with internal stakeholders and external regulatory agencies
Qualifications
  • Extensive experience in global regulatory leadership (15+ years)
  • Strong staff and organizational development experience
  • Broad experience in regulatory disciplines (global/regional strategy, labeling, clinical, nonclinical, CMC)
  • Direct experience in authoring and filing regulatory documentation
  • Advanced degree (MD, PhD, PharmD, JD, MS, MBA) preferred
Location

East coast, with intermittent travel to New Jersey (Princeton), as needed

Benefits
  • Annual Performance Bonus Plan
  • Long Term Incentive Plan
  • Medical, dental, and vision coverage
  • Life insurance
  • Disability insurance
  • 401(k) savings plan
  • Flexible spending accounts
  • Employee assistance program


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

    Job Title: Senior Director, Global Regulatory Portfolio LeadSun Pharmaceutical Industries, Inc. is seeking a highly experienced Senior Director, Global Regulatory Portfolio Lead to join our team. As a key member of our Global Regulatory Affairs Leadership Team, you will be responsible for providing leadership for the regulatory strategy of one or more...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries Full time

    Job Title: Senior Director, Global Regulatory Portfolio LeadThe Senior Director, Global Regulatory Portfolio Lead, is a key member of the Global Regulatory Affairs team at Sun Pharmaceutical Industries. This role is responsible for providing leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas.Key...


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

    Job SummaryThe Senior Director, Global Regulatory Portfolio Lead will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. This role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA.Key Responsibilities Serve as key corporate...


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

    Job Title: Senior Director, Global Regulatory Portfolio LeadThe Senior Director, Global Regulatory Portfolio Lead, is a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA. This role is responsible for providing leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more...


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

    Job SummarySun Pharmaceutical Industries, Inc. is seeking a highly experienced Senior Director, Global Regulatory Portfolio Lead to provide strategic leadership for the company's global regulatory affairs. The successful candidate will be responsible for developing and implementing regulatory strategies to secure approval and maintain licenses in multiple...


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

    Job SummaryThe Senior Director, Global Regulatory Portfolio Lead will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. This role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA. The successful candidate will have extensive...


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

    The Senior Director, Global Regulatory Portfolio Lead, is a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, Global Regulatory Affairs. This role is responsible for providing leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. The successful...


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

    Job Title:Director, Global Regulatory LeadJob Summary:The Director, Global Regulatory Lead will be responsible for providing strategic direction and guidance on regulatory matters for assigned brand programs. This includes developing and executing regulatory strategies, providing regulatory pathway for product development, and acting as the US agent for...


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

    Senior Director, Global Regulatory Affairs Strategy **Job Summary** We are seeking a highly experienced Senior Director, Global Regulatory Affairs Strategy to provide regulatory affairs strategic leadership for our company and novel drug development programs. **Key Responsibilities:** * Develop and execute novel drug regulatory strategy * Ensure...


  • 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...


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

    Job SummaryThe Director, Global Regulatory Lead will be responsible for providing strategic direction and guidance for product development, ensuring compliance with regulatory requirements, and communicating with regulatory agencies. This role will also involve developing and executing regulatory strategies, managing relationships with external regulatory...


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

    Job OverviewLynkx Staffing LLC is seeking a highly skilled Global Director Regulatory Affairs Strategy to lead our client's global teams in the development and execution of regulatory strategy.Key ResponsibilitiesLead Regulatory Affairs Functional Teams (RAFTs) to ensure high-quality strategic regulatory input is provided to optimize regulatory outcomes and...


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

    Job OverviewLynkx Staffing LLC is seeking a highly skilled Global Director Regulatory Affairs Strategy to lead our Pharmaceutical client's global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs.Key ResponsibilitiesLead/support Regulatory Affairs Functional Teams (RAFTs) to...


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

    Senior Director, Global Regulatory Affairs StrategyAs a key member of our team at Sun Pharmaceutical Industries, Inc., you will play a critical role in shaping the company's regulatory affairs strategy for novel drug development programs. Your expertise will be instrumental in ensuring compliance with ICH and local country regulatory requirements, as well as...


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

    Job Title:Senior Director, Regulatory Affairs StrategyJob Summary:We are seeking a highly experienced Senior Director, Regulatory Affairs Strategy to provide strategic leadership for our company's regulatory affairs and novel drug development programs. The successful candidate will be responsible for developing and executing the overall regulatory strategy,...


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

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. 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...


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

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. 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...


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

    Senior Director, Regulatory Affairs Strategy LeadThe 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...


  • Princeton, New Jersey, United States SUN PHARMA Full time

    Job Title: Director, Global Regulatory LeadThe Director, Global Regulatory Lead is responsible for providing strategic direction and guidance for product development and regulatory submissions. This role requires a strong understanding of regulatory requirements and the ability to communicate effectively with cross-functional teams.Key...


  • Princeton Meadows, New Jersey, United States Genmab Full time

    About the RoleGenmab is seeking a highly experienced Senior Director, Global Drug Safety to join our team. As a key member of our Global Drug Safety and Pharmacovigilance team, you will be responsible for leading the development and implementation of our global safety strategy and ensuring the overall safety profile of our assigned products.Key...