Regulatory Affairs Associate Manager, UK & Ireland (Hybrid)

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybrid; GBP 55,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals in the UK is seeking an Associate Manager, Regulatory Affairs to join the UK regional team in a hybrid setting in Uxbridge. You will support marketing authorisations and licence maintenance across UK and Ireland, collaborating with local, regional and global colleagues to drive timely submissions.

Key responsibilities include leading MHRA applications and post-approval variations, coordinating with UK teams, managing regulatory documents, and supporting labelling,

Qualifications

• Bachelor’s or advanced degree in life sciences, pharmacy or related field.
• UK/Ireland regulatory experience up to two years, handling Type II variations.
• Experience with post-Brexit UK applications and MHRA pathways.
• Knowledge of clinical trial requirements and EU medicines development.
• Regulatory database proficiency and ability to manage submissions against deadlines.
• Strong strategic thinking, commercial awareness, and communication.
• UK rare disease experience preferred.

Responsibilities

• Prepare, compile and lead timely MHRA marketing applications and post-approval variations.
• Support submission strategies, negotiate with MHRA and communicate with UK/Ireland teams.
• Author, review and manage module documents, UK Paediatric Investigational Plans and meetings.
• Support UK labelling, artwork and related reviews of risk minimisation material.
• Represent regulatory across EU regional team with cross-functional partners.
• Maintain local regulatory knowledge and support UK/Ireland clinical trials and inspections.
• Develop best-practice user guides, work instructions and SOPs.
• You bring a proactive, collaborative approach to regulatory challenges.

Skills

Regulatory experience

Strategic thinking

Communication skills

Global matrix teamwork

Education

Life sciences degree

Tools

Regulatory databases

MHRA processes

Job description

Regeneron Pharmaceuticals in the UK is seeking an Associate Manager, Regulatory Affairs to join the UK regional team in a hybrid setting in Uxbridge. You will support marketing authorisations and licence maintenance across UK and Ireland, collaborating with local, regional and global colleagues to drive timely submissions.

Key responsibilities include leading MHRA applications and post-approval variations, coordinating with UK teams, managing regulatory documents, and supporting labelling,