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. In addition, the position provides administrative and technical support for regulatory activities before and after product authorization, supporting the maintenance of marketing authorizations and the management of related variations.

Your major accountabilities

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