Quality Recruiting. Established Experts.

Executive Director, Regulatory Affairs

Reference Number: 3899
Location: NY

Our client is a leading biotechnology company known for scientific and operational excellence. They have asked us to assist them in their search for an Executive Director, Regulatory Affairs.

Major tasks and responsibilities will include:

  • Interprets feedback from regulatory authorities, policies, and guidelines.
  • Leads the development of regulatory strategic plans either directly in conjunction with project teams or through direct reports.
  • Leads the preparation of major clinical submissions mandatory for regulatory approval.
  • Collaborates with project teams to resolve complex project issues.
  • Strategically interprets, plans, and communicates regulatory requirements internally to ensure governmental approval.
  • The incumbent will be responsible for quality and timeliness of IND/CTA and BLA/MAA submissions. Interacts with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
  • Successfully plans, organizes, supervises and/or conducts regulatory activities in close collaboration other functional areas.
  • Assures compliance with regulations and with project team timelines and milestones.
  • Provides organizational support and manages personnel.

We seek candidates with the following qualifications:

  • Advanced degree (PhD or PharmD) required.
  • Must have experience with IND/CTA and BLA submissions activities.
  • Requires relevant pharmaceutical industry experience.
If interested, please email your resume as a Word attachment to us, reference 3899.  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.