Regulatory Affairs Manager, CMC - Home Based | Meet Recruitment

Regulatory Affairs Manager, CMC - Home Based

  • 450 GBP - 450 GBP
  • Hybrid, Cambridge, United Kingdom
  • Contract
** New Contract - Regulatory Affairs Manager, CMC - Global Biotech - Hybrid, Cambridgeshire **

Thrilled to be working on this brand new long term contract vacancy with my Global Biotech client based in the UK.

We are searching for a Regulatory Affairs Manager, CMC to join their team for a minimum period of 12 months.

Specific Job Requirements
We have a 12 month contract opportunity for a Manager Regulatory Affairs CMC to join our Regulatory Affairs Team based in Cambridge.

Core Duties include:
  • 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 of regulatory requirements, including ICH requirements and regional requirements
  • Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
  • Well versed and competent with regulatory documentation and submission management systems
  • Excellent verbal, written and interpersonal communication skills are required
  • Must have excellent organizational skills and an ability to work on a number of projects with tight timelines.
This is a hybrid role in which you will be required to work office based for 3 days per week.

If you are suitable, available and interested in this post, please do not hesitate to get in touch.

Brendan Mulvaney 
020 3019 3985
Brendan Mulvaney Lead Consultant

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