Regulatory Operations Submission Manager

Location
Macclesfield
Salary
£600 per day
Posted
01 Apr 2021
Closes
01 May 2021
Ref
50309
Contact
Julie Marshall
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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.

Salary:
£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.
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 Operations Submission Manager role will be based at our clients site in Macclesfield, Cheshire.

Apply:
Please quote reference 50309.