Responsibilities

• Oversee the development and implementation of robust CMC regulatory strategies for all gene therapy development programs, anticipating phase-appropriate and future commercial requirements in close collaboration with Technical Operations and Quality colleagues
• Lead discussions with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally to refine CMC development strategies
• Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers based on prior knowledge and current environment of the GTx landscape
• Serve as regulatory voice and provide CMC guidance to internal teams and lead cross-functional teams to prepare briefing packages, Module 3 and 2.3 sections for INDs, and equivalent IMPD sections for CTAs
• Assess the regulatory impact of proposed manufacturing process changes
• Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports
• Effectively build, maintain, and motivate a high-performing regulatory CMC team, including hiring, developing, coaching, and mentoring diverse, talented, and driven staff
• Actively participate in building an outstanding regulatory team, leveraging operational excellence to implement innovative regulatory strategies efficiently
• Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines. Lead reg-CMC intelligence activities
• Support Quality and CMC team during GMP inspections
• Participate in external trade organizations, related industry conferences, and opportunities to engage with health authorities to be at the forefront of evolving regulations


No matter your role at BridgeBio, successful team members are:
• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• A minimum of a Bachelors Degree required (life sciences disciplines strongly preferred) with approximately ten years of experience in the biotechnology or pharmaceutical industries in regulatory affairs or related functions in drug/biologics development/manufacturing 
• Gene Therapy CMC Experience required
• Great attention to detail, ability to work on multiple projects with tight deadlines, and ability to work independently
• Demonstrated experience leading eCTD formatted submissions, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements, for drugs and/or biologics
• Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
• Ability to communicate regulatory expectations that pertain to the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams
• Excellent oral and written communication and time management skills are essential
• Demonstrated ability to work effectively with and/or lead cross-functional team activities, e.g., research, clinical, and TDO teams
• Ability to develop regulatory plans and strategies while proactively identifying risks
• Ability to work on multiple tasks with strong attention to detail to meet company objectives
• Knowledge of ICH, GCP, GMP, and other relevant global guidelines
• Excellent computer skills, e.g., MS Word, Excel, PowerPoint, and electronic document management software/systems

What We Offer

• 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