Executive Director, Regulatory CMC
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Job Description
Executive Director leading regulatory CMC strategies for Investigational and marketing applications. Collaborating with cross-functional teams to ensure submissions and lifecycle management at BridgeBio Pharma.
Responsibilities:
- Provide strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products
- Partner closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.
- Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests)
- Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.)
- Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
Requirements:
- Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered)
- Typically 12–15+ years of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products—tailor as needed)
- Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred)
- Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks)
- Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment
- Excellent writing, communication, and executive presentation skills
- You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.
Benefits:
- a market-competitive total rewards package
- base pay
- annual performance bonus
- company equity
- generous health benefits
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