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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.

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

Company:
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.

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

Rewards:
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

Apply:
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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