Advanced Therapies CMC Specialist

3 weeks ago


London, Greater London, United Kingdom Northreach Full time

Key Responsibilities:

We are seeking a highly skilled and detail-oriented Regulatory CMC Specialist to join our team. This is an exciting opportunity to contribute to cutting-edge treatments in the Advanced Therapies sector.

About the Role:

  1. Prepare and review high-quality CMC documentation for regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs) specific to cell therapy and ATMP products.
  2. Collaborate closely with manufacturing, quality assurance, R&D, and clinical teams to compile technical data for regulatory submissions.
  3. Serve as the regulatory CMC point of contact for ATMP-specific projects, ensuring alignment with manufacturing and clinical development objectives.

About You:

  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Cell Biology, or related sciences.
  • Minimum of 3–5 years' experience in a Regulatory CMC role, with direct experience in cell therapy, gene therapy, or ATMPs.
  • In-depth understanding of regulatory requirements for ATMPs, including compliance with FDA, EMA, and ICH guidelines.

What We Offer:

  • Competitive salary (£80,000 - £100,000 per annum)
  • Flexible hybrid working environment with 3 days in the London office
  • The opportunity to work on transformative therapies at the forefront of medicine
  • Professional development opportunities in a rapidly growing field


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