Sr. Director, Regulatory Affairs - CMC
BridgeBio
4 days ago
Remote friendly (San Francisco, CA)
United States
Corporate Functions
Responsibilities:
- Lead CMC regulatory strategy, planning, and execution across IND/CTA, NDA/MAA, post-approval submissions, and global registrations.
- Partner with CMC, Quality, Regulatory Operations, and cross-functional stakeholders to deliver timely, high-quality submissions aligned with global health authority expectations.
- Advise on CMC regulatory risks, change controls, health authority interactions, and submission strategies.
- Coordinate and review responses to health authority requests; ensure conformance of technical documentation, manufacturing/validation info, and labeling.
- Mentor/coach junior team members and provide oversight for vendors/assigned staff.
- Use AI-enabled tools and digital technologies to improve efficiency, quality, and consistency while meeting company policies/data governance.
- Support global (ROW) submissions (e.g., MENA, LATAM, APAC) and coordinate regional filing requirements.
Qualifications/Skills:
- BA/BS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field (advanced degree preferred).
- Extensive Regulatory Affairs CMC experience in biotech/pharma; experience supporting NDA/MAA submissions for new chemical entities in pre-/post-approval.
- Experience leading complex global submissions, including ROW regions (MENA, LATAM, APAC).
- Strong knowledge of global health authority regulations, CMC development/manufacturing, and Quality documentation.
- Proven ability to lead through influence in a matrixed organization; strong cross-functional collaboration and communication.
- Experience mentoring/coaching others; people management preferred but not required.
- Experience using AI-enabled/digital tools in regulatory/technical workflows while maintaining compliance.
- Travel as needed (~10–20%).
Benefits (USA):
- 401(k) match; ESPP; pre-tax commuter benefits; referral bonus; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision; HSA + FSA; fertility/family-forming benefits; mental health support; hybrid flexibility; flexible PTO + company holidays; paid medical and parental leave.
- Lead CMC regulatory strategy, planning, and execution across IND/CTA, NDA/MAA, post-approval submissions, and global registrations.
- Partner with CMC, Quality, Regulatory Operations, and cross-functional stakeholders to deliver timely, high-quality submissions aligned with global health authority expectations.
- Advise on CMC regulatory risks, change controls, health authority interactions, and submission strategies.
- Coordinate and review responses to health authority requests; ensure conformance of technical documentation, manufacturing/validation info, and labeling.
- Mentor/coach junior team members and provide oversight for vendors/assigned staff.
- Use AI-enabled tools and digital technologies to improve efficiency, quality, and consistency while meeting company policies/data governance.
- Support global (ROW) submissions (e.g., MENA, LATAM, APAC) and coordinate regional filing requirements.
Qualifications/Skills:
- BA/BS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field (advanced degree preferred).
- Extensive Regulatory Affairs CMC experience in biotech/pharma; experience supporting NDA/MAA submissions for new chemical entities in pre-/post-approval.
- Experience leading complex global submissions, including ROW regions (MENA, LATAM, APAC).
- Strong knowledge of global health authority regulations, CMC development/manufacturing, and Quality documentation.
- Proven ability to lead through influence in a matrixed organization; strong cross-functional collaboration and communication.
- Experience mentoring/coaching others; people management preferred but not required.
- Experience using AI-enabled/digital tools in regulatory/technical workflows while maintaining compliance.
- Travel as needed (~10–20%).
Benefits (USA):
- 401(k) match; ESPP; pre-tax commuter benefits; referral bonus; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision; HSA + FSA; fertility/family-forming benefits; mental health support; hybrid flexibility; flexible PTO + company holidays; paid medical and parental leave.