YOUR CONTRIBUTION
As a Regulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. This will include the following activities:
- CMC Documentation: Create, review, and update high-quality CMC documentation to obtain and maintain product approvals, ensuring compliance with global regulatory requirements; support the creation of IMPDs for clinical trial applications
- Change Control: Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status
- Response Management: Handle and manage inquiries related to quality documentation from authorities, ensuring timely and accurate responses
- Project Coordination: Oversee regulatory CMC projects, communicate with Merz representatives and partners, and coordinate third-party services
- Regulatory Strategy: Develop regulatory CMC strategies and represent regulatory requirements in project teams and interdisciplinary teams
- Regulatory Intelligence: Maintain a detailed understanding of global and national CMC regulatory requirements and best practices
