Regulatory Affairs Associate Manager – UK & Ireland

BioSpace; Uxbridge (MA); Hybrid; USD 70,000 - 102,000; Full time

Job summary

Regeneron is seeking an Associate Manager, Regulatory Affairs to join our UK regional team, supporting UK and Ireland markets in a hybrid setting. You will lead timely marketing applications and post-approval variations through MHRA pathways, and collaborate with local, regional and global colleagues.

The role also covers regulatory submissions, UK labelling and related reviews, plus ongoing compliance for EU regional activities and clinical trial applications. A life sciences degree is required.

Qualifications

• Bachelor’s or advanced degree in life sciences, pharmacy or a related field.
• UK regulatory experience, up to two years, handling Type II variations and MHRA approvals.
• Knowledge of EU medicines development and clinical trial requirements.
• Regulatory database proficiency and ability to manage parallel submissions against deadlines.

Responsibilities

• Prepare, compile and lead MHRA marketing applications and post-approval variations.
• Support submission strategies and communicate implementation to UK/Ireland teams.
• Author, review and manage module documents, responses and UK Paediatric Investigational Plans.

Skills

Regulatory knowledge

UK regulatory experience

Stakeholder communication

Team collaboration

Education

Bachelor’s or advanced degree in life sciences

Tools

Regulatory databases

Job description

Regeneron is seeking an Associate Manager, Regulatory Affairs to join our UK regional team, supporting UK and Ireland markets in a hybrid setting. You will lead timely marketing applications and post-approval variations through MHRA pathways, and collaborate with local, regional and global colleagues.

The role also covers regulatory submissions, UK labelling and related reviews, plus ongoing compliance for EU regional activities and clinical trial applications. A life sciences degree is required.