Regulatory CMC Associate Director

  • Salary: Up to £90 per hour LTD
  • REF Number: 00051699
  • Consultant: Dennis Beltman
  • Contact: 01438 870011
  • Date Published: 17.09.2021
  • Sector: Non-Specific
  • Location: Cambridge, East Anglia, North West
  • Discipline: Regulatory Affairs

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 role is 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 buildinnovative, 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 effectiveRA 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

Your Background:

  • Candidates musthave 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 holdermanagement (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.
  • Oncology experience – particularly in international submissions (south Asia market would be advantageous)

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 CMC Regulatory Associate Director role can be based remotely, spending 1-2 days a week on site in either Macclesfield or Cambridge

Apply:

Entitlement to work in the UK is essential. For more information, please contact Dennis on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 51699.

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