Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations across development programs
Partner closely with CMC, Quality, Regulatory Operations, and cross-functional stakeholders to ensure timely, high-quality regulatory submissions aligned with global health authority expectations
Provide strategic guidance on CMC regulatory risks, change controls, health authority interactions, and submission strategies to support program objectives and regulatory compliance
Coordinate and review responses to CMC-related health authority requests and ensure regulatory conformance of technical documentation, manufacturing information, validation activities, and labeling content
Mentor and coach junior team members and provide oversight for vendors and/or assigned staff, including prioritization, feedback, and support for development activities
Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory deliverables while adhering to company policies and data governance standards
Contribute to global regulatory activities, including demonstrated experience supporting Rest of World (ROW) submissions (e.g., MENA, LATAM, APAC) and coordinating regional filing requirements and strategies
Where You'll Work
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
Requirements
BA/BS degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related scientific discipline required; advanced degree preferred
Extensive Regulatory Affairs CMC experience within the biotechnology and/or pharmaceutical industry, including successful support of NDA/MAA submissions for new chemical entities in pre- and post-approval environments
Demonstrated experience leading complex global regulatory submissions, including Rest of World (ROW) regions (e.g., MENA, LATAM, APAC), with ability to navigate regional regulatory requirements and coordinate cross-regional filing strategies
Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and Quality documentation standards, with the ability to apply regulatory strategy in complex development environments
Proven ability to lead through influence in a matrixed organization, including strong cross-functional collaboration, strategic thinking, project management, communication, and problem-solving skills
Demonstrated experience mentoring, coaching, and developing others; prior direct people management experience preferred but not required
Demonstrated experience utilizing AI-enabled or digital tools to improve efficiency, quality, or decision-making in regulatory or technical workflows while maintaining compliance with company policies and data governance standards
Ability to travel as needed (approximately 10-20%) to support business and regulatory activities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated sala
Benefits
Health insuranceRemote work optionsEquity / stock optionsPerformance bonus
Additional Information
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
Bridgebio · San Francisco - 1800 Owens