Regulatory Operations Submission Manager

  • Salary: £600 per day
  • REF Number: 00050309
  • Consultant: Julie Marshall
  • Contact: 01438 842964
  • Date Published: 01.04.2021
  • Sector:
  • Location: Alderley Park, Macclesfield, Home/Field Based
  • Discipline:

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 offeredon 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 ascientific 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 yearsof 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 andan 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: For more information, please contact Lucy on 01438 870011 or email Please quote reference 50309.

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