Job Description
Job Title: Regulatory Affairs Team Lead (UK/EU)
Job Type: Full-time, Permanent
Location: High Wycombe, Buckinghamshire, UK (Hybrid)
Remuneration: Up to £80,000 + 7.5% Bonus
An opportunity working for a growing specialty pharmaceutical business that focuses on CNS products and hospital injectables as a Regulatory Affairs Team Lead/Manager. The role reports to the Director of Regulatory Affairs.
This role is ideal for someone with a strong understanding of regulatory frameworks, excellent attention to detail, and the ability to work cross-functionally to support product development and approvals. Within this role, you will manage a team of 4 officers. Previous line management is a must as well as real technical expertise.
This role plays a pivotal part in driving regulatory support for EU operations, contributing significantly to achieving company financial targets and fostering growth. This position holds a critical responsibility in harmonising regulatory efforts for EU products of the UK portfolio, particularly post-Brexit, where the business's Marketing Authorisation Holder (MAH), while regulatory oversight remains under the UK portfolio team.
Additionally, this role actively supports in-licensing and acquisitions across the UK and EU ...