CK Group are recruiting for a Senior CMC Regulatory Executive to join a company in the healthcare industry at their site based in Brentford on a contract basis for 12 months.
Daily Rate:
£431 PAYE or £550 Umbrella ? this role is inside IR35
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.
Senior CMC Regulatory Executive Role:
- Accurately assessing the Chemistry, Manufacturing and Controls (CMC) regulatory impact to proposed changes.
- Creation of efficient and robust strategic CMC lifecycle submission plans & overseeing the successful completion of the committed plan.
- Preparation of high quality CMC detailed regulatory documents, liaising closely with other personnel to ensure accuracy of such records.
- Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
- Proactively pursuing process improvement and sharing of best practice
Your Background:
- Extensive CMC regulatory experience, including Post Approval CMC regulatory experience: small molecule lifecycle management/change control experience, drug product and drug substance.
- Strong and recent post-approval CMC experience with expert knowledge of the requirements to maintain a compliant marketing authorization application
- CMC authoring experience essential, including authoring of module 3 and authoring of CMC variations.
- Experience responding to manufacturing site change controls and providing CMC regulatory advice and strategies.
- Detailed proven knowledge and experience of global CMC regulatory requirements.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55522 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 55522
Website: CK Group
- Posted: 12th May 2023
- Expires: 9th June 2023
