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
We are looking for a talented and motivated regulatory affairs leader to help develop and execute regulatory strategies aimed at the most efficient regulatory pathway for development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Plan, compile, review, and submit regulatory documents, including initial INDs/CTAs/NDAs and amendments or supplements, independently or with limited oversight
- Represent Regulatory at cross functional team meetings
- Provides strategic regulatory guidance internally on study-level decision-making
- Keeps study team informed of regulatory activities in the context of study team management meetings
- Manage tracking of regulatory/ethics submissions and approvals across all studies
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.
We are looking for a talented and motivated regulatory affairs leader to help develop and execute regulatory strategies aimed at the most efficient regulatory pathway...
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