Job Details
Senior Regulatory Affairs Manager
4976
Posted: 25/09/2024
- £60000
- Slough, Berkshire, United Kingdom
- Permanent
Senior Regulatory Affairs Manager
Warman O'Brien have been appointed to search for a Regulatory Affairs Manager for a globally renowned generics business, to support their growing team based in the UK.
The role is needed due to an increase in workload as the team looks to expand. This is a hybrid role with an expectation of 2-3 days per week in office.
Responsibilities
Warman O'Brien have been appointed to search for a Regulatory Affairs Manager for a globally renowned generics business, to support their growing team based in the UK.
The role is needed due to an increase in workload as the team looks to expand. This is a hybrid role with an expectation of 2-3 days per week in office.
Responsibilities
- Compiling, preparing and submitting relevant components of the dossier
- Leading relevant agency interactions (EMA and MHRA)
- Advising on Regulatory strategy to your line manager
- Ensuring products remain compliant with relevant legislation
- License maintenance activities including renewals and variations of existing licenses
- Leading Market Authorisation Application submissions
- 5+ years of pharmaceutical Regulatory Affairs experience
- Post approval experience with Generic products
- Experience maintaining Centralised European licenses (CP via EMA)
- Experience maintaining UK licenses via MHRA
- A team player, with a positive and can do attitude
Guy Shipman
Practice Lead | Regulatory Affairs