Regulatory Affairs Director

2 days ago


Princeton, New Jersey, United States SUN PHARMA Full time
Job Title: Director, Global Regulatory Lead

The 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 Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure regulatory requirements are met.
  • Provide regulatory guidance and support to teams.
  • Stay up-to-date with regulatory changes and updates.
  • Develop and maintain relationships with regulatory agencies.
Qualifications:
  • Post-graduation in Clinical Pharmacy or similar.
  • Minimum of 10+ years of experience in global regulatory affairs.
  • Strong understanding of NCE drug development process and regulatory requirements.

This role is part of the Annual Performance Bonus Plan and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs, including medical, dental, and vision coverage, life insurance, disability insurance, and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.



  • 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, New Jersey, United States Genmab AS Full time

    About the RoleGenmab A/S is seeking a highly skilled Director/Associate Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for developing and executing global regulatory CMC strategies for biological products during early and late-stage development, and lifecycle.Key ResponsibilitiesDevelop and execute...


  • 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 SummarySenior Director, Regulatory Affairs StrategySun Pharmaceutical Industries, Inc. is seeking a highly experienced Senior Director to lead our regulatory affairs strategy for novel drug development programs. This role will be responsible for developing and executing the overall regulatory strategy, including registration pathways, regulatory agency...


  • 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 Taiho Oncology, Inc. Full time

    Job SummaryTaiho Oncology, Inc. is seeking a highly skilled Regulatory Affairs Operations Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing global regulatory operational activities for all Taiho Oncology, Inc. projects.Key ResponsibilitiesRegulatory Operations Management: Manage global...


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

    Senior Director, Global Regulatory Affairs Strategy The position will provide strategic leadership for regulatory affairs and novel drug development programs at Sun Pharmaceutical Industries, Inc. The individual will be responsible for developing and executing the overall regulatory strategy, including registration pathways, interactions with regulatory...


  • 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...


  • 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...


  • 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.Key ResponsibilitiesDevelop and execute novel drug regulatory strategyEnsure development programs are compliant with ICH regulatory requirements and all local country...


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

    Job SummarySun Pharmaceutical Industries, Inc. is seeking a highly experienced and skilled Regulatory Affairs Leader to join our team as Senior Director, Regulatory Affairs Strategy. This is a key leadership role that will provide strategic direction and guidance on regulatory affairs for our novel drug development programs.Key ResponsibilitiesDevelop 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 StrategyThe position will provide 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 registration...


  • 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...


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

    {"title": "Senior Manager, Regulatory Affairs", "description": "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 role will be responsible for publishing and coordinating tasks for Global RA submission activities, supporting the...


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

    {"title": "Senior Manager, Regulatory Affairs", "description": "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 role will be responsible for publishing and coordinating tasks for Global RA submission activities, supporting the...


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

    Job OverviewLynkx Staffing LLC is seeking a seasoned Director Regulatory Affairs Chemistry Manufacturing & Controls to lead global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs.Key ResponsibilitiesPlan, prepare, and critically review CMC components of regulatory documents...


  • 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 play a crucial role in shaping the company's regulatory strategy.About the RoleWe are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs, to lead our global regulatory affairs team. As a key member of our team, you...


  • 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 play a pivotal role in shaping the company's regulatory strategy. As a key member of the Global Regulatory Affairs team, you will be responsible for publishing and coordinating tasks for Global RA submission activities, supporting the...


  • Princeton, New Jersey, United States Bristol-Myers Squibb Full time

    About the RoleWe are seeking a highly experienced and skilled Executive Director to lead our Regulatory Affairs team in Precision Medicine & Digital Health. As a key member of our organization, you will be responsible for developing and executing global regulatory strategies to support the development of biomarkers, diagnostic tests, devices, and digital...