Regulatory CMC Associate Director
CK Group are recruiting for a CMC Regulatory Associate Director to join a company in the Pharmaceutical industry reporting to site either in Cambridge or Macclesfield on a contract basis for 12 months.
Salary: Up to £90 per hour LTD – this roleis outside IR35
CMC Regulatory Associate Director Role:
- To proactively partner with Global Regulatory CMC Teams on complex global projects for new biologic or other modality, or line extensions and post approval submissions, helping to build innovative, risk based Regulatory strategies
- Will 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
- Will input to and support progressive strategic, tactical or operational, regulatory CMC expertise and direction to Global Reg project teams
- Support managing high level risk by looking at regulatory options and working with the team to make complex judgements, developing innovative risk based solutions and applying progressive comprehensive cross-functional and industry understanding
- Candidates must have a minimum of 5 years Biologics experience, this role is focussed on vaccines so prior experience within this area is essential
- Minimum of 5+ years’ experience in Regulatory Affairs, with focus on CMC
- Supporting product leads – stake holder management (internal and external) e.g. regulatory agencies
- Experience of working in a large global matrix set up, experience of international projects and submissions is essential.
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 CMC Regulatory Associate Director role can be based remotely, spending 1-2 days a week on site in either Macclesfield or Cambridge
For more information, please contact Lucy Stendal on 01246 457739 or email email@example.com. Please quote reference 51689. Entitlement to work in the UK is essential.