20 Oct
Warman O'Brien
London
Regulatory Affairs Manager
Warman O'Brien are searching for a Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK.
The role has arisen due to an increase in workload as the team looks to expand in the UK.
This is a hybrid role with an expectation of 2-3 days per week in office.
Regulatory Affairs Manager - 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
- Mentoring junior employees accordingly
Regulatory Affairs Manager - Requirements
- 7+ years of pharmaceutical Regulatory Affairs experience
- Experienced with small molecule respiratory products
- Experience leading new submissions for Generic products (MAA, Variations)
- Experience maintaining Centralised European licenses
- Experience maintaining UK license
- A team player, with a positive and can do attitude
Please note, you must possess a valid right to work in the UK to be considered for this role.
▶️ Regulatory Affairs Manager
🖊️ Warman O'Brien
📍 London