Job Description
Tech-Transfer Project Manager – Barcelona (Hybrid)
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 authorisations and the management of 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, including support to technological transfers and updates to pharmaceutical documentation.
- Compile and manage documentation for Marketing Aut...