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.

Salary:

  • 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.

Apply:

For more information, please contact Lucy on 01246 457739 or email pharmacontracts@ckagroup.co.uk. Please quote reference 49371.

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