BridgeBio is a biotechnology company designing transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Backed by Sequoia.
About the role
Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC Regulatory Sciences and will support BridgeBio Pharma and its subsidiaries, including Eidos Therapeutics, Calcilytix Therapeutics, and ML Bio Solutions. This position will work with CMC technical teams (Drug Substance, Drug Product, and Analytical Development) and Regulatory Affairs to design and implement control strategies in alignment with ICH and regional regulatory requirements throughout the product lifecycle.
What they're looking for
- PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience
- Combination of experience in CMC development and regulatory authoring is preferred. Background in drug product or analytical development is a plus
- Working knowledge of analytical method development, validation, and global stability requirements
- Ability to develop strategies, make decisions, and advise technical teams in ambiguous regulatory landscapes
- Ability to effectively interface with and/or manage highly skilled internal staff. Ability to work independently as well as in a team. Ability to build good working relationships
More about this role
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.
Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC Regulatory Sciences and will support BridgeBio Pharma and its subsidiaries,...
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