Sr. Director, Regulatory Affairs - CMC
BridgeBio
June 27, 2026
Remote friendly (San Francisco, CA)
United States
Corporate Functions
What You'll Do
- Lead CMC regulatory strategy and execution across development and post-approval programs, ensuring high-quality submissions aligned with global regulatory requirements.
- Serve as a Regulatory CMC subject-matter expert and key cross-functional partner, influencing regulatory decision-making.
- Primarily an individual contributor role with opportunity to mentor, coach, and potentially manage as the organization evolves.
Responsibilities
- Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations.
- Partner with CMC, Quality, Regulatory Operations, and stakeholders for timely, high-quality submissions.
- Advise on CMC regulatory risks, change controls, health authority interactions, and submission strategies.
- Coordinate and review responses to CMC-related health authority requests; ensure conformance of technical/manufacturing/validation/labeling documentation.
- Mentor and coach junior team members; provide oversight for vendors and/or assigned staff.
- Apply AI-enabled tools and digital technologies to improve efficiency, quality, and consistency of regulatory deliverables (per company policies and data governance).
- Support global regulatory activities, including ROW filings (MENA, LATAM, APAC) and regional filing strategies.
Who You Are / Qualifications
- BA/BS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field; advanced degree preferred.
- Extensive Regulatory Affairs CMC experience in biotech/pharma; successful NDA/MAA support for new chemical entities in pre- and post-approval.
- Experience leading complex global and ROW submissions (MENA, LATAM, APAC).
- Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and Quality documentation.
- Ability to lead through influence in a matrixed organization.
- Mentoring/coaching experience; prior people management preferred but not required.
- Experience using AI-enabled/digital tools in regulatory/technical workflows while maintaining compliance.
- Ability to travel ~10–20% as needed.
Benefits (explicitly stated)
- Market-leading compensation; 401(k) match; ESPP; pre-tax commuter benefits; referral bonus; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision premiums; HSA with employer contributions; FSA; fertility/family-forming benefits; expanded mental health support; hybrid work; flexible PTO; paid medical and parental leave.
Work Location
- U.S.-based remote; quarterly (or as needed) visits to San Francisco office.
- Lead CMC regulatory strategy and execution across development and post-approval programs, ensuring high-quality submissions aligned with global regulatory requirements.
- Serve as a Regulatory CMC subject-matter expert and key cross-functional partner, influencing regulatory decision-making.
- Primarily an individual contributor role with opportunity to mentor, coach, and potentially manage as the organization evolves.
Responsibilities
- Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations.
- Partner with CMC, Quality, Regulatory Operations, and stakeholders for timely, high-quality submissions.
- Advise on CMC regulatory risks, change controls, health authority interactions, and submission strategies.
- Coordinate and review responses to CMC-related health authority requests; ensure conformance of technical/manufacturing/validation/labeling documentation.
- Mentor and coach junior team members; provide oversight for vendors and/or assigned staff.
- Apply AI-enabled tools and digital technologies to improve efficiency, quality, and consistency of regulatory deliverables (per company policies and data governance).
- Support global regulatory activities, including ROW filings (MENA, LATAM, APAC) and regional filing strategies.
Who You Are / Qualifications
- BA/BS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field; advanced degree preferred.
- Extensive Regulatory Affairs CMC experience in biotech/pharma; successful NDA/MAA support for new chemical entities in pre- and post-approval.
- Experience leading complex global and ROW submissions (MENA, LATAM, APAC).
- Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and Quality documentation.
- Ability to lead through influence in a matrixed organization.
- Mentoring/coaching experience; prior people management preferred but not required.
- Experience using AI-enabled/digital tools in regulatory/technical workflows while maintaining compliance.
- Ability to travel ~10–20% as needed.
Benefits (explicitly stated)
- Market-leading compensation; 401(k) match; ESPP; pre-tax commuter benefits; referral bonus; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision premiums; HSA with employer contributions; FSA; fertility/family-forming benefits; expanded mental health support; hybrid work; flexible PTO; paid medical and parental leave.
Work Location
- U.S.-based remote; quarterly (or as needed) visits to San Francisco office.