Regulatory Affairs Manager – CMC Europe

  • Salary: £43.80 PAYE
  • REF Number: 00049371
  • Consultant: Lucy Stendall
  • Contact: 01246 457739
  • Date Published: 27.11.2020
  • Closed Date: 09.12.2020
  • Sector: Non-Specific
  • Location: Remote, East Anglia, Home/Field Based
  • Discipline: Regulatory Affairs

CK Group are recruiting for a CMC Regulatory Manager to join a biopharmaceutical company at their site based in Cambridge on a contract basis for 12 months.


  • 43.80 PAYE

CMC Regulatory Manager Role:

  • Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
  • Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
  • Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial and variations)
  • Authoring and coordinating responses to questions across assigned products and countries.
  • Point of Contact with local country regulatory staff
  • Project management of submissions and monitoring status of applications

Your Background:

  • In-depth experience of pharmaceutical/biotechnology or medical device industry
  • Strong record of related experience within Regulatory Affairs (min 5 years)
  • Regulatory knowledge in regional legislation
  • Working with policies, procedures and SOPs
  • Experience with national legislation and regulations relating to medicinal products
  • Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.

Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Location: This CMC Regulatory Manager role will be based either remotely or at our clients site in Cambridge.


For more information, please contact Lucy on 01246 457739 or email Please quote reference 49371.

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