Regulatory CMC Lead

My client is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. They have retained us to fill a growth opportunity for a Regulatory CMC Lead to join their science driven, patient focused culture. Reporting to the Head of Regulatory CMC Strategy, you will serve in a highly visible role and collaborate with a number of cross-functional stakeholders both internally and externally. In this position, you will have the ability to work in an environment where you can make an immediate impact and be part of a creative, science focused team.

Responsibilities:

  • Accountable for management of global and regional CMC submissions and responses to Health Authority CMC questions
  • Author and/or review CMC documentation for Health Authority submissions
  • Proactively participate in the design of global regulatory strategies for the development of gene therapy products
  • Ensuring CMC regulatory issues impacting global regulatory strategy for proposed CMC filings are considered
  • Participate in negotiations with regulatory agencies to resolve CMC issues
  • Lead preparation of meetings with regulatory agencies
  • Drive adherence to regulatory CMC guidelines for development of gene therapy products
  • Represent Global Regulatory CMC on interdisciplinary project teams; partner with Regulatory, Quality, Research, Manufacturing, Nonclinical and Clinical teams

 

Knowledge and Skills:

  • Minimum BA/BS degree in life sciences required, MS/PhD preferred
  • Minimum 5-8 years’ experience or 4-6 in Regulatory Affairs with a MS/PhD
  • Must have demonstrated expertise in technical writing related to CMC submissions, typically gained through 4+ years of relevant experience
  • Must have Biologics experience, Cell/Gene a plus
  • Must have experience in working with cross functional teams
  • Experience and knowledge in the preparation of electronic submissions
  • Knowledge and understanding of US and ex-US regulations and ICH guidelines
  • Experience in viral vaccine or viral vector gene therapy manufacturing is a plus
  • Excellent ability to read, analyze

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