Regulatory CMC Director (remote working)

£700 - £1000 per day LTD
05 May 2021
04 Jun 2021
Lucy Stendall
Regulatory Affairs
Full Time
Contract Type
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.

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.

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.

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

Please quote reference 50531.