Regulatory Affairs Specialist

4 weeks ago


London, Greater London, United Kingdom Northreach Full time
Job Description

We are seeking a highly skilled and detail-oriented Regulatory CMC Specialist to join our dynamic regulatory affairs team.

As a key member of the team, you will play a pivotal role in driving regulatory compliance for transformative therapies. Your expertise in cell therapy and ATMPs will be invaluable in ensuring that we meet the highest standards of quality and compliance.

Key Responsibilities:

  • Develop and implement CMC regulatory strategies tailored to cell therapy and ATMP products, considering the unique regulatory landscape for advanced therapies.
  • Prepare and review high-quality CMC documentation for regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs) specific to cell therapy and ATMP products.
  • Collaborate closely with manufacturing, quality assurance, R&D, and clinical teams to compile technical data for regulatory submissions.

Qualifications and Experience:

  • 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.
  • Familiarity with regulatory information management systems (RIMS) and electronic submission tools is advantageous.

Salary: £80,000 - £110,000 per annum

Benefits:

  • Competitive salary and benefits package.
  • 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.
  • Inclusive and collaborative work culture.


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