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.
Lead CMC regulatory strategy and execution across development and post-approval programs, ensuring high-quality submissions aligned with global regulatory requirements. Serve as a strategic Regulatory CMC subject-matter expert and key cross-functional partner, influencing regulatory decision-making and program execution. This role is primarily an individual contributor position with the opportunity to mentor, coach, and potentially manage team members as organizational needs evolve. The ideal candidate brings deep Regulatory CMC expertise, strong cross-functional leadership skills, demonstrated experience with global and ROW filings (e.g., MENA, LATAM, APAC), and practical fluency leveraging AI-enabled and digital tools to improve regulatory workflows and deliverables.
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
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
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 salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary $285,000—$320,000 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For USA based roles:
Financial & Rewards
Health & Well-Being
Skill Development & Career Paths:
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases.
Millions worldwide are afflicted with genetic diseases, but small patient populations and industry reluctance to conduct early-stage development means that for many, treatments have not been forthcoming. We are committed to bridging this gap: between business case and scientific possibility, between patient and hope. BridgeBio creates a bridge from remarkable advancements in genetic science to patients with unmet needs via the entrepreneurial engine required to make life-changing medicines as rapidly as possible.
BridgeBio is committed to developing leaders as well as drugs. We are looking for individuals whose passion for creating life-changing medicines will inspire hands-on engagement and the dogged pursuit of novel solutions in the face of adversity.
