Head of Regulatory Affairs, Poland & CEE - Warsaw

 Regulatory Affairs:

• Manage and Oversee the Regulatory activities for the countries within the cluster, as delegated by the MAH (APTL) and in compliance with local regulations
• Provide regulatory support for the distribution and commercial (Sales) process
• Manage regulatory submissions and lifecycle maintenance activities according to company strategy and ensure registration deadlines are met
• Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements; Ensure that all specific national requirements are met
• Identify and obtain any deficient information to complete the compilation within the allocated time frame
• Verify correctness and completeness of the registration files to be submitted according to local requirements
• Proactively inform the Head of Pharma Affairs (Europe CIS) and other ...