Compliance

• Prepare, compile, and support submission of regulatory dossiers for international markets, ensuring all Module 1 administrative components and GMP registration requirements are met
• Coordinate, review, and quality-check administrative and technical documentation for new product registrations in MENA and other global regions
• Manage regulatory documents and data within Veeva Vault RIM, ensuring accurate metadata, proper workflow routing, and compliance
• Work closely with SMEs to gather required documentation as per country-specific regulations
• Track and maintain submission status, timelines, and documentation in relevant systems to support efficient registration processes
• Support preparation of responses to agency queries in collaboration with internal experts
• Maintain organized records of international regulatory submissions and lifecycle documents

Manager, Regulatory, International Markets – MENA

Senior Manager, EU & APAC Regulatory Affairs