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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
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