Senior Regulatory Executive
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. Hybrid role.
Salary: Per Day £435.72 PAYE / £569.62 UMB
Company: 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.
Location: Brentford. 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.
Rewards: As a PAYE employee you would be entitled to:
- Pension
- Timesheet system
- Bike schemes
Senior Regulatory CMC Executive Role:
- Preparation of high quality, CMC detailed regulatory documents using varied information sources.
- Working to agreed deadlines and maintainingrecords 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.
Your Background:
- CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 andauthoring 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
Apply: For more information, or to apply for this Senior Regulatory CMC Executive please contact theKey Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 54296.
It is essential that applicants hold entitlement to work in the UK