Regulatory Affairs Manager

Regulatory Affairs Manager

North London, Hybrid – (3 days in office 2 WFH)

An exciting opportunity to join a leading pharmaceutical company that specializes in branded and generic products, OTC, and prescription medicines. This role as a Regulatory Affairs Manager will take the lead on lifecycle maintenance and post-approval changes.

In this position as a Regulatory Affairs Manager, you will be responsible for leading many projects in the UK and European markets including working on new registration while supporting a team.

Responsibilities

• Manage a number of new product registrations in the UK and EU and work closely with global colleagues to ensure compliance.  
• Conduct lifecycle maintenance activities including new MAA, variations, renewals, and change of ownership applications.
• Compile/ author module 3 and any other CMC changes.
• Define UK/EU strategy and work cross-functionally with other departments to ensure products are reaching the correct markets.
• Support junior team members with training/ mentoring and potentially line manage junior professionals.

Requirements

• BSc or equivalent in Life Sciences or related area.
• At least 5 years of Regulatory Affairs experience with a focus on the EU market.
• Experience going through MRP and DCP for the UK or EU.
• Led a number of new MAA for the UK and EU markets.
• Must have the right to work in the UK.

This is an excellent opportunity to join a leading company that specialises in generics/ branded products. You will work in a lead position and will be responsible for multiple different products across the EU market.

Please note you MUST be located in the UK and be willing to go into the office 3x a week.

For more details please contact/ to apply for this position please send your updated CV to