Regulatory Operations Submission Manager

£600 per day
01 Apr 2021
01 May 2021
Julie Marshall
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Group are recruiting for a Regulatory Operations Submission Manager to join a company in the Pharmaceutical industry. The role is remote working however some occasional travel to the site in Macclesfield will be required. The role is being offered on a contract basis for 6-12 months.

£600 per day (outside IR35) LTD / Umbrella

Regulatory Operations Submission Manager Role:
  • Responsible for delivery and life cycle management of regulatory submission documents working within Global Technical Operations
  • Lead or participate in cross-functional teams as the BioOps representative to provide submission related expertise
  • Lead the process of critical review of CMC regulatory documents and incorporating multiple internal and external reviews into quality documents
  • Manage activities associated with multiple projects: delivery of documents to submission ready standards
  • Participate or lead template and procedure preparations
Your Background:
  • BS/MSc in a scientific discipline relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc.
  • 6+ years of biopharmaceutical industry experience, including 2 years of writing experience in a regulatory environment.
  • Experience preparing CMC regulatory documents and/or manuscripts is desired.
  • Background in biologics such as monoclonal antibodies and/or vaccines.
  • Must have strong interpersonal skills and an ability to influence.
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 Operations Submission Manager role will be based at our clients site in Macclesfield, Cheshire.

Please quote reference 50309.