YOUR CONTRIBUTION
As a Regulatory Affairs Manager (m/f/d), you will support regional regulatory strategies, approvals, and the life cycle management of medicinal products, ensuring compliance with regulatory and legal requirements. This position is currently limited to a fixed term of 3 years. Your responsibilities will include the following tasks:
- Review Company Core Data Sheets (CCDS)
- Implement CCDS into national product information texts (EEA/CH/UK), coordinate translations, ensure compliance and timely provision
- Initiate, review, and approve artwork changes (EEA/CH/UK) in close cooperation with local regulatory affairs
- Support submissions and responses to authority queries
- Optimize labeling and artwork processes; train colleagues and act as key user for Merz’ artwork management system
- Lead, monitor and further develop the Regulatory Intelligence process in Global Regulatory Affairs