Regulatory CMC Director (remote working)

Location
Home-Based
Salary
£700 - £1000 per day LTD
Posted
05 May 2021
Closes
04 Jun 2021
Ref
50531
Contact
Lucy Stendall
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
CK Group are recruiting for a Regulatory CMC Director to join a company in the Pharmaceutical industry on a contract basis for 10 months. The role will be remote working, however post COVID some site presence would be preferred at either Cambridge or Macclesfield.

Salary:
Daily £700 - £1000 per day LTD

Regulatory CMC Director Role:
• Proactively partner with Global Regulatory CMC Teams on complex global projects for new biologic or other modality, or line extensions and post approval submissions.
• Help to build innovative, risk based Regulatory strategies.
• Lead and/or deliver regulatory CMC components of business related projects across functions, of high quality, consistent and complete, as agreed for the Product strategies.
• May provide effective RA CMC representation on a variety of development product teams.
• Support application of progressive thinking and regulatory CMC expertise to TA and non-TA projects within business RA and business technical functions and help develop innovative regulatory strategies globally.

Your Background:
• Experienced graduate or in a scientific discipline, typically chemistry, pharmacy or a biological science.
• Knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture.
• Typically, strong experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture, might also be considered.
• Awareness of regulatory requirements and submissions pathways.
• Significant project or line management experience in a relevant environment.

Company:
Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

Location:
This Regulatory CMC Director role will be remote working, however Post Covid some on-site presence at Cambridge or Macclesfield is preferred.

Apply:
Please quote reference 50531.