BridgeBio is a biopharma company that pioneers a'moneyball for biotech' approach to reduce risk and unleash innovation. The company values curiosity and experimentation, and is looking for a Sr. Director, Regulatory Affairs to lead CMC regulatory strategy and execution across development and post-approval programs.
Requirements
- BA/BS degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related scientific discipline
- Extensive Regulatory Affairs CMC experience within the biotechnology and/or pharmaceutical industry
- Demonstrated experience leading complex global regulatory submissions
- Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and Quality documentation standards
- Proven ability to lead through influence in a matrixed organization
- Demonstrated experience utilizing AI-enabled or digital tools to improve efficiency, quality, or decision-making in regulatory or technical workflows
Benefits
- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits
- Referral bonus for hired candidates
- Subsidized lunch and parking
- Health & Well-Being benefits
- Flexible, 'take-what-you-need' paid time off and company-paid holidays
- Comprehensive paid medical and parental leave
- Skill Development & Career Paths
