Associate Director/Director, Regulatory Affairs

Our client is a biotechnology company. They have asked us to assist them in a search for an Associate Director/Director, Regulatory Affairs.  

Major tasks and responsibilities include:
  • Participates in the development and implementation of regulatory strategies for company’s therapeutic programs from candidate selection through post-marketing support.
  • Provides guidance to interdisciplinary project teams on product development approaches and regulatory submission requirements.
  • Coordinates the drafting, editing, preparation and submission of regulatory submissions (including routine correspondence, INDs, BLAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications,) with minimal oversight.
  • Communicates with regulatory authorities as directed to further product development programs and keep them in good standing.
  • Maintains current knowledge of FDA and international regulations, guidance and standards applicable to company products.
  • Assists in the maintenance of corporate quality systems in line with current GxP standards, regulations, and company directives.
  • Is Responsible for supervision of Regulatory Affairs Specialist(s).
  • Ensures that each direct report has objectives in alignment with corporate goals and is managing their resources.

We seek candidates with the following qualifications:
  • A BS or PhD degree in a scientific discipline is preferred.
  • At least 5+ years of experience working in Regulatory Affairs (may be supplemented by relevant experience) is required.
  • Experience working with biotechnology products is preferred.
  • Requires knowledge of GCP, GLP, GMP and FDA and ICH guidelines.
  • Must have an understanding/working knowledge of Microsoft Word and Excel.
  • Strong interpersonal, negotiating, and problem-solving skills are required.
  • Must have excellent communication skills, both written and verbal.

If interested, please apply directly to this job posting. No calls 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.
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