Job Title: Regulatory Affairs Manager - Biopharmaceutical Manufacture
Posted: 2020-09-08 10:37:35
Regulatory Affairs Manager - Biopharmaceutical Manufacture
Our client, who is an exciting and pioneering DNA research and development company, is looking for a self-motivated and quick-thinking Regulatory Affairs Manager to join their dynamic team.
Working with several teams across the business you will compile IMPDs, clinical trial applications, INDs, DMFs etc. whilst maintaining a regulatory correspondence file. You will also provide support to the product development team to interpret regulatory requirements of early clinical development and work with them to ensure data and reports meet the necessary standards of external agencies.
To be successful in this position you will need:-
· A minimum of 4 years’ experience working in a regulatory affairs environment, in early clinical development
· Experience in compiling IMPDs and working with manufacturing professionals - essential.
· Experience of regulatory interactions (FDA/EMA/MHRA) related to product/clinical development as well as a working knowledge of all stages of clinical development of biopharmaceuticals and small molecule drugs - essential.
To find out more please contact Andy Cuthbert on 01606 818290 or email ac@entrustrs.com