Cell Therapy Regulatory Expert

3 days ago


London, Greater London, United Kingdom Northreach Full time

Job Description:

We are looking for a Cell Therapy Regulatory Expert to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global regulatory requirements for ATMPs, including gene therapies, tissue-engineered products, and somatic-cell therapies.

About the Job:

  1. Develop and implement CMC regulatory strategies tailored to cell therapy and ATMP products, considering the unique regulatory landscape for advanced therapies.
  2. Monitor and interpret evolving global regulatory guidelines for ATMPs, advising stakeholders on implications for product development and lifecycle management.
  3. Assess and mitigate risks associated with CMC compliance for complex biological systems and advanced therapies.

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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