Senior Manager Regulatory Affairs

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...