Associate Planning Director

1 month ago


London, Greater London, United Kingdom Advanced Resource Managers Full time
Associate Director Regulatory Affairs - CMC

Advanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to join our client, a leading Biotech business through a CRO.

This role will focus on driving and leading regulatory CMC strategy for one of their main partners.

You will provide innovative solutions, including global regulatory therapeutic area expertise, strategic regulatory intelligence, and guidance for product development from preclinical through registration and product optimization.

The team has a preference for someone with strong post-approval experience over pre-approval.

Key Responsibilities:
  • Lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.
  • Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the EMA and regional agencies.
  • Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAA and variations.
  • Post-Approval Compliance and Life Cycle Management:
    • Lead the CMC regulatory management and submission planning of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products.
    • Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.

This is a permanent full-time position offering a competitive salary and an extensive benefits package.


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