Description✓CK Group are recruiting for a Senior Regulatory CMC Executive to join a company in the healthcare industry at their site based in Brentford on a contract basis for 12 months.
✓Per Day £435.72 PAYE / £569.62 UMB
✓Our client is a one of the largest global healthcare companies researching, developing and supplying innovative medicines, vaccines and healthcare products with their global headquarters in the UK
✓They invest around £1bn in research and development in the UK annually.
✓This site is the UK headquarters for the company
✓It houses commercial and business functions as well as scientists and has around 800 staff at the facility.
✓As a PAYE employee you would be entitled to:
✓Weekly/monthly payroll options
✓Senior Regulatory CMC Executive Role:
✓Preparation of high quality, CMC detailed regulatory documents using varied information sources.
✓Working to agreed deadlines and maintaining records to reflect project status
✓Responsible for highlighting and sharing knowledge of regulatory documentation and procedures with others.
✓Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
✓May contribute to process improvement and/or regulatory intelligence projects.
✓CMC authoring experience essential [previous co-ordination role is not sufficient]
✓This should include authoring of module 3 and authoring of CMC variations.
✓You will have strong understanding of CMC regulations, guidelines, procedures and policies.
✓Post Approval CMC experience is required.
✓Experience responding to manufacturing site change controls and providing regulatory advice and strategies.
✓You will have the ability to stablish strong relationships and liaise effectively with business sites worldwide
✓It is essential that applicants hold entitlement to work in the UK
✓Please quote job reference 53867 in all correspondence Show more →