CMC Regulatory Expert

4 days ago

London, Greater London, United Kingdom Northreach Full time
Northreach's Vision:

We aim to be a leader in developing innovative treatments for patients worldwide.

To achieve this goal, we are looking for a talented Advanced Therapy Specialist to join our team.

About the Job:

The successful candidate will be responsible for preparing and reviewing high-quality CMC documentation for regulatory submissions.

This includes ensuring compliance with global regulatory requirements for ATMPs, managing submissions for variations and renewals, and responding to regulatory agency queries.

Responsibilities:
  1. Regulatory Documentation:
    • Prepare and review CMC documentation for regulatory submissions.
    • Ensure compliance with global regulatory requirements.
  2. Cross-Functional Collaboration:
    • Collaborate with manufacturing, quality assurance, R&D, and clinical teams.
    • Serve as the regulatory CMC point of contact for ATMP-specific projects.
  3. Regulatory Strategy:
    • Develop and implement CMC regulatory strategies.
    • Monitor and interpret evolving global regulatory guidelines.
  4. Risk Assessment:
    • Assess and mitigate risks associated with CMC compliance.
    • Conduct gap analyses of existing ATMP CMC dossiers.
  5. Documentation and Systems Management:
    • Maintain accurate CMC regulatory documentation and databases.
    • Support audits and inspections by regulatory authorities.
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, including compliance with FDA, EMA, and ICH guidelines.
  • Hands-on experience with global regulatory submissions and lifecycle management for advanced therapies.
  • Strong expertise in the manufacturing, characterization, and quality requirements for cell therapy/ATMP products.
  • Exceptional analytical and organizational skills with attention to detail.
  • Excellent written and verbal communication skills.
Salary and Benefits:
  • A competitive salary: £60,000 - £80,000 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.
  • Inclusive and collaborative work culture.

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