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Job Title: Associate Director/Director Regulatory Affairs CMC

Job Number: 21687

Location: Lexington, MA

Job Description

The Associate Director/Director of Regulatory Affairs CMC will be responsible for supporting development programs providing CMC expertise and leadership including review for CMC regulatory submissions to U.S. and European health authorities. Working closely with the CMC team and the Program Teams, the Associate Director/Director will develop a global regulatory CMC strategy in support of all development programs.

Responsibilities

  • Work closely with CMC team and program teams to develop CMC regulatory submission strategies, prepare and review content, and maintain submission timelines to successfully meet program and company objectives
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • Lead coordination efforts for CMC content of original INDs, IND amendments, investigational medicinal product dossiers (IMPD), development safety update reports and BLA’s/MAA’s
  • Liaise with health authorities and lead preparations for health authority meetings with CMC focus
  • Establish, manage and maintain a knowledge base of current and emerging CMC regulatory requirements and guidelines in the CMC field
  • Ensure that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements
  • Assume additional responsibilities as assigned to supplement efforts outside of CMC focus (Orphan Drug Applications, Advanced Therapy Medicinal Product Classifications, etc.)

Required Skills

  • Bachelor’s degree in life sciences required; advanced degree preferred
  • Minimum of 10 years in Regulatory Affairs (CMC) with a B.S./B.A., or 8 years with M.S. or Ph.D.
  • Knowledge of drug development, with strong preference for large molecule/biologics experience
  • Excellent knowledge of U.S., EU and ICH requirements and guidelines, with experience as regulatory authority liaison
  • Experience with gene therapy products and advanced therapy medicinal products very desirable
  • Ability to work effectively as a leader with a proven track record of effective collaboration as part of cross functional program teams
  • Excellent written and oral communication skills
  • Excellent interpersonal and negotiation skills with strong ability to develop effective relationships with key stakeholders
  • Strong ability to multi-task, set priorities, and meet timelines in an innovative small company environment
  • Ability to analyze complex issues and to develop proactive recommendations that translate strategy into action
  • Some domestic and international travel required

 

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