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 assigned region. This will include the following activities:
- Dossier Preparation: Develop and maintain high-quality regulatory documentation for assigned regions, 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
