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CMC Regulatory Project Manager

Macclesfield, Cheshire   •  Contract/Temporary, Full time

CK Group are recruiting for a CMC Regulatory Project Manager to join a company in the Pharmaceutical industry on a contract basis for 12 months.

Per Day £400 PAYE OR £520 Umbrella, this role is inside IR35

Our client is a global research-based bio pharmaceutical company with a major UK presence who are committed to making a meaningful impact on people?s lives with life-changing medicines. This is a worldwide brand name which will not only look fantastic on your CV for years to come but also offer inspiring and rewarding work.

This role can be either home based or at one of our client?s sites in either Cambridge or Macclesfield.

People are at the very heart of this organisation, and their facilities support this. You will find an onsite gym, restaurants, parking, on-site holiday childcare and much more!
Along with:

  • Weekly/monthly payroll options
  • Pension
  • Timesheet system
  • Bike schemes

CMC Regulatory Project Manager Role:

  • Contribute to and lead regulatory CMC components of business-related projects
  • Define the content of CMC submissions and review and approve regulatory CMC documents
  • Represent CMC RA on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated
  • Responsibility for change management

Your Background:

  • Degree or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science
  • Breadth of knowledge of manufacturing, project, technical and regulatory management.
  • Direct Regulatory Affairs CMC experience
  • Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
  • Stakeholder & Project management skills

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53664 in all correspondence.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 53664
  • Posted: 13th May 2022
  • Expires: 10th June 2022

CK Group

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