Cell Therapy Regulatory Expert
3 days ago
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:
- Develop and implement CMC regulatory strategies tailored to cell therapy and ATMP products, considering the unique regulatory landscape for advanced therapies.
- Monitor and interpret evolving global regulatory guidelines for ATMPs, advising stakeholders on implications for product development and lifecycle management.
- 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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