Quality Recruiting. Established Experts.

Director Regulatory Affairs

Reference Number: 3772
Location: MA

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

Major tasks and responsibilities will include:

  • Develops and implements effective regulatory and related strategies for the development and commercialization of products.
  • Ensures adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements.
  • Develops content and format for regulatory submissions, related supplements, amendments, and clinical protocols.
  • Advises and oversees internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes.
  • Oversees preparation, submission, application, and routine reports as required by internal departments.
  • Sustains excellent relationships with regulatory agency personnel.
  • Responds to requests for additional data.
  • Organizes and manages participation in meetings.
  • Negotiates directly with regulatory authorities regarding company filings.
  • Develops, implements, and reviews current policies and practices issued by Federal and international regulatory agencies.

We seek candidates with the following qualifications:

  • Bachelor’s degree required. Master’s degree or PhD highly preferred.
  • Must have 10+ years of related pharmaceutical industry experience, and 8+ years of clinical regulatory experience.
  • Requires significant experience in leading meetings with the FDA.
  • Must have experience with programs leading to accelerated approval.
  • Requires successful completion of NDA and MAA application(s).
  • Must have working knowledge of eCTD submissions and supportive technologies.

If interested, please email your resume as a Word attachment to us, reference 3772.  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.