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 EMEA. The position is limited to 3 years and includes the following activities:
- Develop and maintain high-quality regulatory documentation for EMEA region, ensuring compliance with internal and international standards
- Coordinate and submit applications for new registrations, approvals, and GMP verifications, adhering to national regulatory requirements
- Implement local regulatory changes and update product information texts and packaging in line with company and national standards
- Manage regulatory life-cycle activities, including renewals, variations, and post-approval commitments, in collaboration with internal and local teams
- Handle deficiency letters from regulatory authorities, ensuring timely and accurate responses
- Communicate regional regulatory needs to global teams, coordinate with local partners, and manage third-party service providers
- Contribute to regulatory strategies and stay updated on regional regulatory requirements and best practices
- Prepare for and participate in meetings with regulatory authorities, collaborating with local and global stakeholders
