YOUR CONTRIBUTION
As a Regional Regulatory Affairs Manager (m/f/d), you will provide regional regulatory support for the strategic development, approval, and life cycle management of drugs, ensuring compliance with regulatory and legal requirements in the region APAC-MEA. This will include the following activities:
- Dossier Preparation: Develop and maintain high-quality regulatory documentation for responsible region, ensuring compliance with internal and international standards
- Marketing Authorization: Coordinate and submit applications for new registrations, approvals, and GMP verifications, adhering to national regulatory requirements
- Change Control & Product Information: Implement local regulatory changes and update product information texts and packaging in line with company and national standards
- Life-Cycle Management: Manage regulatory life-cycle activities, including renewals, variations, and post-approval commitments, in collaboration with internal and local teams
- Response Management: Handle deficiency letters from regulatory authorities, ensuring timely and accurate responses
- Project Coordination: Communicate regional regulatory needs to global teams, coordinate with local partners, and manage third-party service providers
- Regulatory Strategy & Intelligence: Contribute to regulatory strategies and stay updated on regional regulatory requirements and best practices
- Agency Interactions: Prepare for and participate in meetings with regulatory authorities, collaborating with local and global stakeholders
