Director - Regulatory Affairs, CMC

March 12

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BridgeBio

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BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• This experienced Regulatory Affairs team member will provide CMC regulatory expertise and support for development project work, including oversight of CMC regulatory submissions working closely with CMC QA and regulatory stakeholders. • This individual will represent CMC Regulatory Affairs on CMC and Regulatory sub-teams with respect to RA CMC deliverables for Rest of World (ROW) filing, including as required, Submission and Change Control teams. • This individual will ensure the planning, development, and finalization of high-quality CMC documentation designed to meet regulatory requirements while overseeing US post-approval submissions and ex-US global registrations as applicable. • The successful candidate is expected to develop strong relationships with various departments and different management levels, including interactions across BridgeBio affiliates. The scope ranges from early clinical development through submission and maintenance of license applications.

🎯 Requirements

• BA/BS degree in chemistry or similar required, post-graduate degree preferred • Successful experience leading Regulatory CMC activities for multiple regulatory filings in pre-and post-approval settings, including experience filing an NDA/MAA for an NCE • Excellent oral and written communication skills with proven ability to analyze and organize information logically • Thorough knowledge of drug development, health authority regulations and guidelines, CMC and Quality documentation standards, with the ability to apply knowledge to guide the delivery of regulatory documents efficiently • Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure • Excellent interpersonal, active listening, and influencing skills • Strong collaboration, teamwork, organizational skills, and attention to detail • Prior management experience preferred

🏖️ Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak • An unyielding commitment to always putting patients first. Learn more about how we do this here • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science • A place where you own the vision – both for your program and your own career path • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game • Access to learning and development resources to help you get in the best professional shape of your life • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time • Partnerships with leading institutions • Commitment to Diversity, Equity & Inclusion