Regulatory CMC Associate Director or Director

This client is a clinical-stage biopharmaceutical company focused on the discovery and development of transformational therapies for patients with serious, rare diseases.  They are seeking a Regulatory CMC Associate Director or Director to develop CMC regulatory strategy plans and content for CMC filing for multiple development programs.  You will serve as a liaison to regulatory authorities for CMC issues while also working closely with manufacturing and CMO vendors. Now is an exciting time to join this growing company and make an immediate impact on the lives of patients!

Responsibilities:

  • Develop CMC aspects of strategic regulatory plans and author content for IND and CTA filings for development programs.
  • Serve as liaison to global regulatory authorities on CMC matters.
  • Provide submission team leadership for all CMC submissions and contribute to the preparation of pre-submission packages.
  • Advise global CMC team relative to regulatory guidance and requirements for submission dossiers.
  • Track and evaluate Regulatory policy and guidance relative to CMC specific issues.
  • Keep abreast of scientific developments in key CMC areas.
  • Prepare Regulatory Strategy /Risk Assessment and prepare plans of actions regarding CMC related topics. Keep Regulatory leadership informed on plans/risks/issues.
  • Provide scientific and regulatory CMC assessment for the evaluation of new business opportunities.

Knowledge and Skills:

  • BA/BS degree in life sciences, MS preferred
  • Eight years of industry experience with five or more years of experience in Regulatory CMC for the development of pharmaceuticals and/or biologics.
  • Experience as primary regulatory author for CMC sections of IND and CTA documents. Experience working on a BLA, NDA, or MAA preferred.
  • Strong knowledge of FDA, EMA and GMP regulations/guidelines.
  • Experience working directly with the FDA regarding CMC issues.
  • Experience working with manufacturing and CMOs a plus.
  • Ability to work independently and thrive in a fast-paced environment.
  • Good technical background and project management skills.
  • Must have excellent communication skills, attention to detail, and the ability to think creatively.
  • Flexible team player with the ability to be a situational leader when required

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