Regulatory Affairs Manager – Pharma – Ref.: JVM040220V
Our client is focused on the development and distribution of both licensed and unlicensed medicinal products with a drive to more into the licensed area through moving some of their own unlicensed drugs across into fully licensed products as well as in licencing others. As a result, they need to appoint a senior Regulatory Affairs Manager to take responsibility for guiding and managing regulatory aspects of projects intended for inclusion into Marketing Authorisation Applications; This includes preparing and maintaining dossier documentation, CMC documentation, licence variations and product information in the UK, Europe or globally. This is a senior ire reporting to the CSO and will be responsible for Liaising with regulatory groups, manufacturing facilities and external contractors to ensure the relevant documentation is available.
The role requires an experienced regulatory affairs expert possible looking for their 1st managerial position Thorough understanding of the CTD modules, non-clinical, clinical and CMC is required as is a detailed understanding of regulatory pathways and strategies in the UK and ideally Europe.