About the client: We are working with a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, including both psychiatric and neurological disorders.

Job description

The main focus of the role is to prepare, manage, and submit regulatory documentation to Health Authorities and customers in both European and non-European markets, ensuring full compliance with regulatory requirements, internal procedures, and quality standards throughout the product lifecycle. The position also supports administrative and technical activities for regulatory actions before and after product authorization, maintaining marketing authorizations and managing related variations.

Responsibilities

• Prepare, manage, and submit Quality and Labelling variation packages, providing regulatory expertise to support product registration and lifecycle management.
• Review and evaluate regulatory dossiers, inclu...