Regulatory Affairs Manager

We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs Team.

WHAT WILL YOU DEAL WITH?

Strategic Regulatory activities:

• Supporting the definition of global and regional regulatory strategies, identifying optimal registration pathways based on product characteristics, development stage and target markets.


• Providing strategic guidance to clients on regulatory requirements and potential risks, ensuring compliance with EU and international frameworks.

Regulatory Affairs activities:

• Preparing, reviewing, and overseeing regulatory documentation for Marketing Authorization Applications (MAA), including CTD Modules.


• Ensuring accuracy, completeness, and consistency of regulatory submissions, in line with international guidelines and c...