Associate Director of Global Regulatory Affairs CMC

4 days ago


Philadelphia, Pennsylvania, United States Adaptimmune Full time
Job Title: Associate Director of Global Regulatory Affairs CMC

Adaptimmune is a pioneering cell therapy company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.

Our company culture is built on trust, inclusion, collaboration, and a commitment to honesty and bravery in our pursuit of transforming lives through cancer treatment.

Key Responsibilities:
  • Develop and execute global CMC regulatory strategies to support product success throughout their lifecycle.
  • Lead the development and filing of CMC modules/updates, including life cycle management, and generate submission-ready content for Quality/CMC sections of clinical trial and marketing authorization applications.
  • Provide regulatory guidance to cross-functional teams on CMC regulatory strategy, ensuring compliance with global regulatory requirements.
  • Collaborate with internal and external teams to develop and execute robust CMC regulatory strategies.
  • Plan, execute, and manage regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, and briefing documents.
  • Lead interactions with FDA and other Health Authorities for CMC-related topics.
  • Perform life cycle management for marketed products, including regulatory impact assessments and preparation of CMC documentation for variations and other post-marketing submissions.
Qualifications & Experience:
  • Bachelor's Degree in a scientific discipline; advanced degree preferred.
  • Minimum 8 years of relevant pharmaceutical/biotech experience, including 5 years of Regulatory Affairs CMC experience.
  • Experience with pharmaceutical development of drug substance and drug products, including analytical characterization and manufacturing process development.
  • Proven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market support teams.
  • Successful track record of providing robust regulatory advice and making reasoned decisions on regulatory issues.
  • Experience with filing and maintenance of regulatory dossiers, including CTAs, INDs, IMPDs, BLAs/MAAs.
  • Ability to effectively liaise with Regulatory Agencies and work in cross-functional teams.

Adaptimmune is an equal opportunities employer and welcomes applications from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status, or other legally protected category.



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