YOUR CONTRIBUTION
As a Team Lead Regulatory CMC Writing (m/f/d), you will be the central contact point for our manufacturing site for development and maintenance of regulatory documentation to support creation of actual regulatory dossiers. This will include the following activities:
- Preparation of CMC documentation in compliance with internal requirements and in collaboration with the manufacturing organization
- Supervise a Regulatory CMC Writing Manager including coaching, performance review, ensuring compliance, and monitoring performance and its improvement
- Review draft documentation with the CMC RA and the respective site
- Conduct initial impact assessments, ensures justified documentation of changes
- Provide documentation per LoQ scope and timeline, and coordinates related tasks with the manufacturing site
- Define and coordinate required information and documentation with the manufacturing site and contractors to meet agreed regulatory timelines
- Support GMP inspections as needed
- Keep current on global CMC regulations and best practices
