Senior Manager Regulatory Affairs
Location
cambridge, england
Job Type
Full-time
Category
Management & Operations
Posted
June 20, 2026
PE Global is currently recruiting for a Regulatory Affairs Manager for a 12 month contract role with a leading multinational Pharma client based in Cambridge.
Hybrid – only once a month in the office.
Note: references to “local” in this job description may describe work with multiple markets or a centralized health authority/procedure for multiple markets. This includes the EU Regulatory Leads (EURLs) working with the European Medicines Agency (EMA) for the EU markets.
Job Responsibilities
- Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross‑functional team.
- With general supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
- Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
- Creates, reviews, and approves source text for countr...