Regulatory Affairs Manager

Regulatory Affairs Manager

Warman O'Brien are searching for a Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures generics 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

Regulatory Affairs Manager - Requirements

• 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

Please note, you must possess a valid right to work in the UK to be considered for this role.