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Regulatory Affairs Manager - CMC

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Parkside
πŸ“ Cambridge, United Kingdom
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Location Cambridge
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Posted June 14, 2026
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Commute Local Area
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Job Description

My client is a global biopharma company. They are seeking a Regulatory Affairs Manager (CMC) to join our Regulatory Affairs Team based in Cambridge on a 12 month contract.

Hybrid working

Key Responsibilities

  • Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa)
  • Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
  • Co-ordinate the preparation of responses to CMC questions from regulatory authorities
  • Maintain an up-to-date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner
  • Knowledge, Experience and Skills

  • Must have significant experience in regulatory affairs and an extensive knowledge...
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    πŸ“ Location Details

    πŸŒ†
    City
    Cambridge
    πŸ—ΊοΈ
    Country
    United Kingdom
    πŸš—
    Commute
    Local Area

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