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CMC Manager - UK, Remote

Contract: Contract role

Closing Date: 31/03/23

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This is an opportunity to join our team in a contract role that provides opportunities to work with a range of stakeholders.

The Role

Supporting all the regulatory activities assigned as part of the Workstreams & Projects including, but not limited to:

  • Authoring and preparing (module 3) CMC submissions, e.g. (planning, authoring, reviewing, coordination, and submission) for assigned projects/products, while applying the global strategy to submissions.
  • Authoring and/or reviewing high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global strategies, current trends and guidelines.
  • Aligning action trackers and communications within client RA functions and providing oversight collaboration across the RA community by engaging with county organizations/affiliates.
  • Supporting team discussions and the preparation of CMC regulatory strategies, risks and key issues for supply limiting variations, combining variations, and implementation-related decisions.
  • Aligning with the current CMC lead and the responsible team regarding any ongoing dossier updates in order to coordinate regulatory actions on the same brand and ensure proper project updates.
  • Preparing timely updates to regulatory compliance systems, metadata and downstream communications.


  • At least 2-5 years of experience in Regulatory Affairs, CMC.
  • Experience in handling manufacturing site transfers, batch scale changes, and establishing comparability is preferred.
  • Ability to work proactively with stakeholders and to communicate regulatory requirements and proposals.
  • Experience in emerging markets and international regions preferred.
  • Project management abilities.
How to Apply

For further details, please send your CV to:

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

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