CK Group are recruiting for a Global Regulatory CMC Contractor to join a pharmaceutical company at their site based in Uxbridge on a contract basis (inside IR35) for 12 months. 50% office attendance required for when offices open.
A global biopharmaceutical company who are committed to helping patients who are living with a wide range of debilitating and chronic diseases, from cancer to psoriasis.
The role is based at our client\'s site in Uxbridge which is easily commutable from central London and the Home Counties region, with great commuter and international travel links.
Your main duties will include:
. The development of the CMC regulatory strategy for submissions with an emphasis on international regions. These submissions include CTA/MAA regulatory filings
. Collaborating with Regulatory CMC project leads and other relevant line functions to prepare CMC submission documents, registration dossiers, and responses to health authorities for responsible regions
. Participating in the regulatory evaluation of CMC change controls by liaising with Regulatory CMC project leads and Regulatory Affairs International to determine regulatory impact for responsible regions.
The ideal candidate for this role will have a Life Science background, with proven background in CMC Regulatory Affairs documents (variations, responses and CTAs) and with registration dossiers for worldwide use.
- Knowledge of ICH guidelines and CMC regulations for international regions
- Experience in developing global CMC regulatory strategy
- Experience in managing post approval Regulatory CMC activities globally
Entitlement to work in the UK is essential. Please quote reference 51618.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Hendre Moolman
- Phone: 01438 743 047
- Reference: 51618
Website: CK Group
- Posted: 9th September 2021
- Expires: 7th October 2021