Advanced Therapies Regulatory Professional

2 days ago


London, Greater London, United Kingdom Northreach Full time

Job Description

We are seeking a highly skilled and detail-oriented Regulatory CMC Specialist with expertise in cell therapy and ATMP to join our dynamic regulatory affairs team. This is an exciting opportunity to contribute to cutting-edge treatments in a fast-evolving field.

  • Regulatory Documentation and Submissions:
    • Prepare and review 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.
    • Manage submissions for variations, renewals, and responses to regulatory agency queries.
  • 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, ensuring alignment with manufacturing and clinical development objectives.
  • Regulatory Strategy:
    • 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.
  • 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, ensuring readiness for inspections and compliance with global regulatory expectations.
  • Documentation and Systems Management:
    • Maintain accurate CMC regulatory documentation and databases specific to ATMPs, ensuring audit readiness.
    • Support audits and inspections by regulatory authorities, particularly regarding manufacturing and quality processes for cell therapies.


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