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Senior Manager, Regulatory Affairs

Ref #: 350
Location: North Carolina
Salary: 130,000 Per Annum
Sector: Regulatory Affairs
Type: Fixed

What you will be doing:

  • Serve as the primary liaison with US regulatory authorities and is responsible for assisting with the development and implementation of regulatory strategy
  • Timely management and preparation of high quality regulatory documents and submissions
  • Regulatory life-cycle management for licensed products (e.g. preparation, coordination and submission of variations/supplements/annual reports, facility/product registrations)
  • Act as the company's primary point of contact for FDA
  • Establish effective working relationships with Regulatory Agencies and major regulatory consulting agents
  • Management of Commercial requests to ensure content of promotional materials is compliant with applicable regulations
  • Ensure regulatory applications comply with applicable regulations and guidance documents
  • Coordinate the Health Authority response team
  • Prepare and organize advice meetings with regulatory authorities
  • Represent regulatory as member of Project Team(s) and assure RA input into designated projects

Our ideal candidate will have:

  • Advanced life science degree (MS, PhD)
  • 8+ years of regulatory affairs experience required, preferably experience with biologics
  • Experience in regulatory submissions and post-authorization life-cycle management
  • Sound knowledge of FDA guidelines
  • Proven direct interactions with FDA

Please apply today!