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Senior Director, Regulatory CMC

Reference Number: 4140
Location: MA

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

Major tasks and responsibilities will include:

  • Provides strategic regulatory CMC leadership supporting the development of multiple innovative products.
  • Authors CMC technical reports as source documents, as well as eCTD sections for INDs, and NDAs.
  • Forms CMC response strategies and submissions to regulators.
  • Manages the completion of CMC submission documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
  • Creates CMC briefing packages for meetings with health authorities.
  • Spearheads the preparation for and conduct of CMC meetings with health authorities.
  • Leads negotiations with regulatory agencies to resolve CMC issues and guides proactive interactions with regulators.
  • Supports interactions with regulatory agencies during GMP and pre-approval inspections.
  • Critically reviews CMC documentation supporting regulatory applications.
  • Assesses proposed manufacturing process changes and provides strategic regulatory guidance to enable regulatory and filing implementation.
  • Identifies and assesses CMC regulatory risks.
  • Prepares and delivers effective presentations for internal and external audiences.

We seek candidates with the following qualifications:

  • Bachelors of Science in a scientific discipline required. Advanced degree highly preferred.
  • Must have a minimum of 8 years of pharmaceutical industry experience in CMC Regulatory Affairs, supporting both development projects and commercial products.
  • Extensive experience in pharmaceuticals submissions required.
  • Requires evidence of successful submissions to the FDA and demonstrated evidence of writing regulatory documents.
  • Must have established working knowledge of US guidelines and regulations.
  • Strong knowledge of eCTD elements and structure and regulatory technical writing skills required.

If interested, please email your resume as a Word attachment to us, reference 4140.  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.