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Director of Regulatory Affairs CMC

1 month ago

San Francisco, United States SciPro Full time

Director Regulatory Affairs CMC

San Francisco, CA (Hybrid)

6 month initial contract (likely extension and conversion to FTE)


This client is a clinical-stage precision oncology biotech focused on creating cutting-edge therapies to target cancer treatments.


Responsibilities:

  • Develop and implement CMC regulatory strategies to facilitate the clinical development and eventual marketing approval of investigational products
  • Oversee the creation and upkeep of the PDM and quality sections for regulatory submissions, including initial IND, IMPD/CTA, NDA, MAA filings, and amendments, as well as preparing responses to inquiries from Health Authorities (HAs)
  • Act as the PDM regulatory representative on project teams, offering CMC regulatory support to ensure compliance with relevant regulatory requirements during the clinical development of investigational products
  • Collaborate with the corporate regulatory team, CMC subject matter experts, and/or CROs to identify regional and country-specific CMC requirements, driving PDM submission timelines to achieve business objectives
  • Engage with the FDA and other global regulatory bodies as needed. Provide regulatory assessments and guidance on PDM-related change controls, deviations, and investigations throughout the product lifecycle


Requirements:

  • Preferably an advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field is preferred
  • The candidate should have over 12 years of experience in pharmaceutical/biotech drug development, including more than 4 years in global CMC regulatory affairs, with expertise in PDM development for NCEs/small molecules
  • They should have a proven track record in leading global PDM-related submissions (IND, IMPD/CTA, NDA, MAA, etc.)
  • A deep understanding of US and international GMP quality regulations, current industry practices, and the ability to interpret and apply these to development projects and regulatory issues for marketed products is essential.