Executive Director, Regulatory CMC

📋 Description

• • As an Executive Director of Regulatory CMC at BridgeBio Pharma, you will be at the forefront of developing life-changing medicines for patients with unmet needs, embodying the company's pioneering "moneyball for biotech" approach.
• • This pivotal role demands strategic and operational leadership for all global Chemistry, Manufacturing, and Controls (CMC) regulatory activities, spanning the entire product lifecycle from early development through commercialization.
• • You will be instrumental in shaping and executing comprehensive CMC regulatory strategies for investigational and marketing applications, including INDs, CTAs, IMPDs, MAAs, and NDAs, as well as managing lifecycle changes.
• • Serving as the primary CMC regulatory lead for one or more critical programs, you will also contribute to the functional leadership of the Regulatory CMC team, ensuring scalability and excellence as the company's portfolio expands.
• • A key responsibility involves providing leadership, coaching, and professional development to Regulatory CMC staff and external contractors, fostering a high-performing team environment.
• • You will spearhead the preparation, meticulous review, and timely approval of CMC sections for all regulatory submissions, ensuring compliance with global standards and requirements, including Module 3 and Quality Overall Summaries.
• • This role requires proactive engagement with global health authorities such as the FDA, EMA, MHRA, and PMDA, including developing and managing CMC-related briefing packages, meeting requests, and providing expert responses to information requests.
• • You will be responsible for ensuring a consistent and accurate interpretation of global CMC regulations and guidances, anticipating emerging regulatory trends, and proactively identifying and mitigating potential risks.
• • Collaboration is central to this role; you will partner closely with cross-functional leaders in CMC, Quality, Technical Operations, Clinical Development, and Regulatory Affairs to align strategies and ensure seamless product development, licensure, and lifecycle management.
• • The position offers a unique opportunity to work in a dynamic, fast-paced environment where scientific innovation and patient focus are paramount.
• • You will contribute to a culture that values curiosity, experimentation, and the ethical and thoughtful use of AI to enhance clarity, speed, and quality in regulatory processes.
• • BridgeBio's mission is to develop transformative medicines for patients with genetic diseases, and this role is critical in ensuring that the manufacturing and quality aspects of these therapies meet the highest regulatory standards.
• • You will play a key role in navigating the complex regulatory landscape for novel therapeutic modalities, including biologics, small molecules, cell and gene therapies, or combination products.
• • The ideal candidate will possess a deep understanding of global CMC regulatory requirements, including ICH Q-series guidelines, regional specificities, and post-approval change control frameworks.
• • Success in this role hinges on the ability to lead complex, cross-functional teams, influence senior stakeholders within a matrixed organization, and communicate intricate regulatory information effectively.
• • You will be empowered to drive regulatory decisions, ensuring that product development timelines are met while maintaining the highest standards of quality and compliance.
• • This position is based remotely in the USA, offering flexibility while requiring occasional visits to the San Francisco office for strategic meetings and team collaboration.
• • You will be a key contributor to BridgeBio's mission of reengineering the future of biopharma by ensuring robust and compliant CMC regulatory pathways for groundbreaking therapies.
• • Embrace the challenge of achieving the impossible and join a team dedicated to making a significant impact on patient lives through scientific excellence and regulatory expertise.