Regulatory Operations Submission 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 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
- 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 firstname.lastname@example.org. Please quote reference 50309.