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Responsibilities:
- Define and execute global CMC regulatory strategies for investigational and marketing applications.
- Serve as the primary CMC regulatory lead for one or more programs and/or as functional head for Regulatory CMC.
- Provide leadership, coaching, and development for Regulatory CMC staff and contractors.
Submissions & Health Authority Interactions:
- Lead preparation, review, and approval of CMC sections for regulatory submissions.
- Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions.
- Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.