Manager / Sr. Manager, Regulatory Affairs
August 9
🔄 Hybrid – San Francisco
Description
• The Manager/Sr. Manager, Regulatory Affairs will be a strategic thinker and responsible for overseeing (with support) the regulatory assessment and research on regulatory precedence to evaluate regulatory strategies for development programs focused on rare diseases. • As assigned, this individual will also be responsible for application maintenance activities, amendments/supplements, and other policies and procedures. • This position is a generalist role and will be part of a high-performing regulatory team working across the neurology space within ML Bio/BridgeBio. • The individual for this role will have collaborative and leadership skills to allow for successful cross-functional interactions within the ML Bio organization.
Requirements
• Advanced degree (M.S., Pharm.D., Ph.D.) or B.S. Degree in Biology, Immunology, or related field • Minimum of 2 years of relevant regulatory affairs experience with an advanced degree or 5 years with a Bachelor’s degree, with proven strategic involvement with small molecule drugs and/or biologics development is required • Rare Disease experience is preferable; experience with late-stage development work is highly desirable • Ability to analyze and interpret scientific data and regulations to apply to a drug development program • Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box • Excellent written and oral communication skills • Fluent with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat (PDF) rendering software
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
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