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Director Regulatory Affairs

Reference Number: 3502
Location: NY

Our client is a leading biopharmaceutical company.  They have asked us to assist them in their search for a Director of Regulatory Affairs. 

Major tasks and responsibilities will include:

  • Provides counsel, training, and interpretation of the FDA’s and other regulatory authorities’ feedback, policies, and guidelines.
  • Acts as a liaison between the company and regulatory authorities.
  • Works with urgency to advance portfolio and capitalize on breakthrough designation of lead asset.
  • Interprets, plans, and communicates requirements to ensure FDA approvals are obtained.
  • Participates in developing the strategy and executing the submission of INDs/BLAs.
  • Responsible for leading module 1/commercial regulatory strategy.
  • Interacts with other functions in the preparation, review, and completion of documents for regulatory submissions.
  • Provides guidance to prepare and effectively complete advisory board and ad-com meetings.
  • Responsible for keeping the Executive Leadership Team and the Development Team informed of regulatory status and significant regulatory issues.  Presents and implements project related regulatory strategy with all Project Teams.
  • Ensures compliance with Project Team timelines and milestones.
  • Effectively plans, organizes, and conducts formal meetings with regulatory agencies.  Interacts with key personnel in regulatory agencies to ensure the review and approval of development plans, timely resolution of issues, and approval of studies.
  • Responsible for building and maintaining key external relationships across regulatory agencies and key stake holders on a global scale.
  • Hires FTE and/or consultants to support regulatory operations and other regulatory activities when necessary.
  • Acts as liaison with outside regulatory consultants to lead overarching regulatory strategy for the company.

We seek candidates with the following qualifications:

  • Requires a BS, MS, or PhD degree in a Life Sciences discipline or equivalent.
  • Must have a minimum of 10 years of regulatory experience with prior experience filing an NDA or BLA.
  • Must have a strong understanding of the drug development process.
  • Must be familiar with oncology/hematology drug development and regulatory requirements.  In the absence of oncology/hematology experience, rare/orphan experience is desirable.
  • Must have extensive experience in cGMP and other Regulatory (CMC, preclinical, etc.) compliance requirements.
  • Requires experience with US, EU, and global regulatory activities including product registrations, IND, BLA and MAA filings, and safety reporting.
  • Requires a working knowledge of post-marketing regulatory commitments.
  • Must have the ability to influence the direction of complex regulatory issues, solicit information, persuade others, and shape outcomes.

If interested, please email your resume as a Word attachment to us, reference 3502.  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.