Cell Therapy Regulatory Expert
3 weeks ago
We are seeking a highly skilled Regulatory CMC Specialist to join our dynamic team in London.
This is an exciting opportunity to contribute to cutting-edge treatments in a fast-evolving field. As a key member of the regulatory affairs team, you will be responsible for ensuring the highest standards of quality and compliance in the development and submission of cell therapy and ATMP products.
Key Responsibilities:
- Develop and implement CMC regulatory strategies tailored to cell therapy and ATMP products.
- Prepare and review high-quality CMC documentation for regulatory submissions.
- Cross-functional collaboration with manufacturing, quality assurance, R&D, and clinical teams.
Requirements:
- 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.
Salary: £100,000 - £130,000 per annum
Benefits:
- Competitive salary and benefits package.
- Flexible hybrid working environment.
- Opportunity to work on transformative therapies.
- Professional development opportunities.
- Inclusive and collaborative work culture.
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