Director, Regulatory CMC
BridgeBio Pharma · Remote
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Role summary
Director-level regulatory affairs position leading Chemistry, Manufacturing, and Controls (CMC) strategy for rare disease drug programs. Reports to senior leadership and drives regulatory submissions and compliance across early-stage to late-stage development projects in a fast-paced biotech environment.
What they're looking for
- Advanced degree in chemistry, pharmaceutical sciences, or related field
- 10+ years CMC regulatory experience in pharmaceutical or biotech industry
- Proven track record leading regulatory submissions to FDA or international authorities
- Expert knowledge of CMC guidance documents and regulatory requirements
- Strong project management and cross-functional team leadership skills
What you'll be doing
- Lead CMC regulatory strategy and submissions for multiple pipeline programs
- Oversee chemistry, manufacturing, and controls documentation and compliance
- Partner with research, development, and operations teams on regulatory pathways
- Mentor and develop regulatory affairs staff members
Privacy & handoff
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