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Global Regulatory Affairs CMC Manager
Job Summary
A company is looking for a Manager, Global Regulatory Affairs CMC.
Key Responsibilities:
- Manage and oversee GRA Change Controls process across PTC's product portfolio
- Coordinate the preparation of periodic regulatory documents
- Support regulatory leads in developing regulatory strategy and execution of regulatory submissions
Required Qualifications:
- Bachelor's degree in scientific discipline and a minimum of 1-3 years of Regulatory Affairs experience in a pharmaceutical or biotechnology environment
- Basic knowledge of the FDA, EMEA and ICH regulations and guidelines for CMC
- Proficiency with Microsoft Office, MS Project, Veeva, SharePoint and MS Teams
- Experience in project management and coordination in a cross functional setting
- Results driven and keen attention to details
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COMPLETE JOB DESCRIPTION
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