Accessibility Links

Global Director Regulatory Affairs

  • Job type: Permanent
  • Location: Bedminster
  • Salary: $180000 - $200000 per annum
  • Job reference: MLSN111017937
  • Sector: EPM Scientific, Regulatory
  • Date posted: 10/11/2017
A leading global pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products is looking for a Global Director Regulatory Affairs to join their growing regulatory team. 

The Global Regulatory Director is responsible for developing and implementing US/ Canada and global regulatory strategies to secure and maintain market approval in the assigned therapeutic area. 

  • Ensures compliance with global regulatory requirements.
  • Leads a team of global regulatory professionals for development and marketed products.
  • Key internal leader and driver of regulatory policy and strategy for assigned products.
  • Leads preparation of global, US and Canadian regulatory product strategies for assigned products.
  • Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
  • Communicates to the regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by senior management.
Education Required/ Preferred
  • Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Relevant advanced degree is preferred
  • Proven 3-5 years of a leadership role with strong management skills.
  • Experience in a broad scope of functions, including CMC and clinical operations and/or project management, is strongly desirable
  • Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams
  • Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies
Similar jobs
Scientific Director - Medical Communications
  • Job type: Permanent
  • Location: Parsippany
  • Salary: $135000 - $150000 per annum, Benefits: Healthcare + Bonus + PTO
  • Description Leading Medical Communications agency is seeking a Scientific Director with experience in utilizing strategy to develop and implement medical content. As the Scientific Director you...
Associate Director of Global Oncology Marketing
  • Job type: Permanent
  • Location: Bridgewater
  • Salary: $140000 - $170000 per annum
  • Description One of the world’s largest pharmaceuticals firms is looking to hire an Associate Director of Global Marketing for their oncology portfolio. This is a growth...
Quality Consultant (Biologics/Device Focused)
  • Job type: Contract
  • Location: City of Edinburgh
  • Salary: Competitive
  • Description Calling for all Quality Consultants Part Time - Initial 6 months contract   My client is an innovative UK device manufacturer and biologic company focused on
Medical Director - Medical Communications
  • Job type: Permanent
  • Location: Parsippany
  • Salary: $120000 - $150000 per annum, Benefits: Healthcare + Bonus + PTO
  • Description Job description High performing agency located in New Jersey is looking for a full time Medical Director. As Medical Director, you will lead medical writing...
Quality Product Leader
  • Job type: Permanent
  • Location: Amsterdam
  • Salary: Competitive
  • Description Job type: PermanentLocation: AmsterdamSalary: Highly Competitive salaryJob reference: HYEG  31/07/2017Sector:  EPM Scientific,