Vice President Regulatory Affairs

Vice President Regulatory Affairs and Quality Assurance

My client is seeking a highly motivated, science driven, experienced leader to join their collaborative, rapidly growing biotech company. They are one of the few organizations who are leading novel vaccine development to treat millions of patients world-wide. The Vice President of Regulatory Affairs and Quality Assurance will be instrumental in driving all regulatory efforts with agencies and vendors. As the right arm to the Chief Executive Officer, you will be responsible for developing regulatory strategies to facilitate and expedite product development. The successful professional operates with a high level of enthusiasm, energy, and integrity.

 

Responsibilities:

  • Plan, manage and execute regulatory activities, including submission and maintenance of US and international regulatory filings
  • Serve as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for and facilitating sponsor interactions at regulatory meetings, and ensuring appropriate follow-up
  • Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
  • Expand QA functional capabilities to support CMC, Clinical and R&D activities
  • Represent regulatory in due diligence activities related to partnering opportunities
  • Supervise and mentor direct report(s), and work closely with external consultants

 

Knowledge and Skills:

  • A minimum of BS in a scientific discipline required; MS or PhD preferred
  • Minimum 12 years regulatory affairs experience required
  • Must have a solid understanding of regulatory – FDA and EU regulatory requirements
  • Must have experience with biologics
  • Must have direct-experience working with CBER
  • Advisory Committee experience preferred
  • Oncology experience a plus

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