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Vice President, Regulatory Affairs

Reference Number: 3810
Location: MA

Our client is a pharmaceutical development company.  They have asked us to assist them in their search for a Vice President, Regulatory Affairs

Major tasks and responsibilities will include:

  • Develops and manages regulatory team.
  • Drives regulatory process.  
  • Provides strategic regulatory leadership for all drug development projects and activities needed to secure approval.
  • Leads coordination, preparation, and timely submission of all regulatory documents.
  • Ensures timely filing and approval of new products.
  • Oversees all Health Authority interactions, acting as primary point of contact.  Leads all interactions, presentations, and negotiations.
  • Participates on Medical-Legal Review Team.
  • Interprets and articulates all FDA (and other regulatory body) communications, expectations, and decisions to internal and external stakeholders.
  • Develops and implements solution based issue resolution strategies.
  • Advises senior management of the potential impact of the changing regulatory environment.
  • Strategically partners with the Vice President of Pharmacovigilance, and collaborates on FDA reporting.
  • Supports post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials.
  • Communicates and collaborates effectively across all departments and functions as regulatory subject matter expert.
  • Maintains and creates relevant SOPs, Work Instructions, and other necessary guidance.

We seek candidates with the following qualifications:

  • Bachelor’s degree in related field required.  Advanced degree highly preferred.
  • Must have 15+ years of pharmaceutical/biotech industry experience in regulatory affairs.
  • Must have 5+ years of demonstrated success in a regulatory team leadership role, and proven management by influence.
  • Requires BLA filing experience.
  • Must have proven negotiation skills, direct experience with the FDA and international agencies, and knowledge of regulations and regulatory process in all global markets.
  • Requires solid understanding of dossier requirements NDA, MAA, IND, IMPD, and CTA.
  • Prior experience with biologics preferred.
  • Requires proven excellence in operational strategy.
  • Must be able to interpret, communicate, and present regulatory information in a succinct manner. 

If interested, please email your resume as a Word attachment to us, reference 3810.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.