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Vice President, CMC Regulatory And Quality
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Full-time
- The VP CMC Regulatory & Quality will lead all aspects of CMC Regulatory Affairs to support global regulatory submissions as well as CMC Quality Assurance and Quality Control for Invivyd’s clinical candidates and commercial products.
- This is a leadership position within Inivyd’s Technical Operations group and as such will provide CMC Regulatory and Quality strategy and managerial leadership within the organization.
- Establish vision and strategies for CMC Regulatory and CMC Quality Assurance and Quality Control, ensuring proper integration with Global Regulatory and Clinical Quality leadership and business systems.
- Lead CMC regulatory submission preparations by setting strategies and directing preparation activities, including scientific writing and critical reviews of regulatory documents.
- Direct the establishment, management, and distribution of a knowledge base of current and emerging CMC regulatory requirements and guidelines, as well as CMC regulatory commitments for Invivyd programs.
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