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Associate Director, Regulatory CMC

Reference Number: 3958
Location: MA

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

Major tasks and responsibilities will include:

  • Oversight of regulatory submissions, which includes filings maintenance, modules processing and circulating for review and approval.
  • Participates in meetings, committees, and regulatory interactions.
  • Provides input to regulatory submission deliverables and objectives, as needed, to meet the corporate goals.
  • Assesses proposed analytical and manufacturing changes for impact on regulatory filings.
  • Works cross-functionally to implement internal electronic systems.
  • Collaborates cross-functionally with all relevant areas to support corporate objectives.

 We seek candidates with the following qualifications: 

  • Bachelor’s degree in biology or related discipline required. Advanced degree highly preferred.
  • Must have a minimum 5 years of pharmaceutical industry experience in regulatory affairs.
  • Experience with regulatory submissions for small molecules, biologics and cell therapies with a focus on CMC, highly preferred.
  • Experience with ADC products is a plus.
  • Must have strong knowledge and understanding of eCTD requirements for submission to US and ex-US regulatory agencies.
  • Requires solid experience utilizing electronic environments for submissions and documentation management.
  • Prior experience preparing for and supporting and/or attending regulatory agency meetings is required.
  • Must have working knowledge of health authority regulations/guidance and requirements, with the demonstrated ability to articulate and apply these requirements to regulatory submissions and company initiatives.
  • Experience with GMP, Quality Systems, GCP and GLP highly preferred. 

If interested, please email your resume as a Word attachment to us, reference 3958.  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.