We are seeking an Associate Scientist to join our team in supporting regional Chemistry, Manufacturing and Control (CMC) strategy, the preparation of documentation, and the execution of regional post-approval submissions and new product registrations. In this role, you will serve as a vital link between Regional and Local Regulatory Affairs and Product Teams.
**Key Responsibilities**:
- Assess regulatory change control by identifying requirements for submissions.
- Track submissions and approvals, ensuring bidirectional communication of status with local regulatory colleagues and global teams.
- Review documentation to support submissions according to local and regional requirements.
- Assist in timely responses to Health Authority queries, ensuring compliance with local and regional regulatory requirements.
- Attend cross-functional meetings, providing input on local and regional requirements and maintaining close communication with local regulatory colleagues and gl...