Sr. Director, Regulatory Affairs - CMC

Responsibilities

• Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations.
• Partner with CMC, Quality, and Regulatory Operations to ensure high-quality submissions aligned with global health authority expectations.
• Provide strategic guidance on CMC regulatory risks, change controls, and health authority interactions.
• Coordinate and review responses to CMC-related health authority requests and technical documentation.
• Mentor and coach junior team members and provide oversight for vendors and assigned staff.
• Apply AI-enabled tools and digital technologies to improve the efficiency and quality of regulatory deliverables.
• Support Rest of World (ROW) submissions, including MENA, LATAM, and APAC regions.

Requirements

• BA/BS degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
• Extensive Regulatory Affairs CMC experience within the biotechnology or pharmaceutical industry.
• Proven track record of supporting successful NDA/MAA submissions for new chemical entities.
• Demonstrated experience leading complex global regulatory submissions, specifically in ROW regions (MENA, LATAM, APAC).
• Strong knowledge of global health authority regulations, CMC development, and manufacturing processes.
• Experience utilizing AI-enabled or digital tools to improve regulatory or technical workflows.
• Ability to travel approximately 10–20% as needed.

Preferred Qualifications

• Advanced scientific degree.
• Prior direct people management experience.

Benefits

• Market-leading compensation and annual performance bonuses.
• 100% employer-paid medical, dental, and vision premiums for employees and dependents.
• 401(k) with employer match and Employee Stock Purchase Program (ESPP).
• Flexible, “take-what-you-need” paid time off and comprehensive parental leave.
• Fertility and family-forming benefits.
• Professional development opportunities via LinkedIn Learning and coaching.

About the Company

BridgeBio Pharma is a biopharmaceutical company dedicated to developing life-changing medicines for patients with unmet needs in rare diseases. Using a unique "moneyball for biotech" approach, we pool projects and expertise to reduce risk and accelerate innovation, building bridges to groundbreaking scientific advancements.