Regulatory Affairs Manager

Role Overview

The Regulatory Affairs Manager is responsible for supporting and managing EU Marketing Authorisation Applications (MAA) , lifecycle activities and supporting new MAAs. The role focuses on EMA submissions , authority interactions, and post-authorisation maintenance for centrally authorised medicinal products.

Key Responsibilities

• Lead and support EU MAAs via the Centralised Procedure (CP) .
• Coordinate preparation, review, and submission of CTD/eCTD dossiers in line with EMA requirements.
• Act as the primary regulatory contact with the EMA .
• Support regulatory strategy for centrally authorised products.
• Manage post-authorisation activities , including variations, renewals, and commitments.
• Prepare and coordinate responses to LoQ, LoOI, and other EMA requests .
• Oversee labeling updates (SmPC, PIL,...