Senior Specialist, Regulatory Registration and Compliance

Key Responsibilities:

• Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation. Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle.
• Review and provide linguistic input for local Product Information and Mock-ups.
• Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients.
• Involvement in project management of the network of local contact persons for Regulatory affairs
• Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes.
• Propose marketing authorization strategies tailored to client needs.
• Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.