Job Description
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
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