CMC Regulatory Professional

4 days ago


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

Responsibilities:

  • Regulatory Documentation and Submissions:
    • Prepare high-quality CMC documentation for regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs) specific to cell therapy and ATMP products.
    • Ensure compliance with global regulatory requirements for ATMPs, including gene therapies, tissue-engineered products, and somatic-cell therapies.
  • Cross-Functional Collaboration:
    • Collaborate closely with manufacturing, quality assurance, R&D, and clinical teams to compile technical data for regulatory submissions.
    • Serve as the regulatory CMC point of contact for ATMP-specific projects.
  • Regulatory Strategy:
    • Develop CMC regulatory strategies tailored to cell therapy and ATMP products.
    • Monitor and interpret evolving global regulatory guidelines for ATMPs.
  • Risk Assessment and Compliance:
    • Assess and mitigate risks associated with CMC compliance for complex biological systems and advanced therapies.
    • Conduct gap analyses of existing ATMP CMC dossiers.
  • Documentation and Systems Management:
    • Maintain accurate CMC regulatory documentation and databases.
    • Support audits and inspections by regulatory authorities.

Key Qualifications:

  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Cell Biology, or related sciences.
  • Minimum 3–5 years' experience in a Regulatory CMC role.
  • In-depth understanding of regulatory requirements for ATMPs.


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