Advancing treatments to improve outcomes and quality of life for patients with hypertrophic cardiomyopathy and related heart conditions. Backed by a16z.
About the role
The (Senior) Director, Regulatory Affairs CMC will serve as the Global CMC Regulatory Lead and provide regulatory CMC leadership for Braveheart Bio’s HCM program. Reporting to the Vice President of Regulatory Affairs, this hands-on individual contributor will develop and execute the global CMC regulatory strategy that carries our lead asset from Phase 3 through registration, launch supply, and lifecycle management. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor's degree required, advanced degree in a life science, pharmaceutical science, or related field (PhD, PharmD, or MS) preferred
- A minimum of 12 years in Regulatory Affairs CMC, including serving as the CMC Regulatory Lead for late-stage or commercial products
- Hands-on experience authoring and reviewing CMC sections for INDs/CTAs and marketing applications (NDAs/MAAs)
- Direct experience supporting commercial readiness, including process validation/PPQ, launch supply, and pre-approval inspection preparation
- Experience with technology transfer and site-to-site comparability
- Experience overseeing CDMOs from a CMC regulatory perspective
More about this role
Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.
With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.
The (Senior) Director, Regulatory Affairs CMC will serve as the Global CMC Regulatory Lead and provide regulatory CMC leadership for Braveheart Bio’s HCM program. Reporting to the Vice President of Regulatory Affairs, this hands-on individual contributor will develop and execute the global CMC regulatory strategy that carries our...
Browse similar: Startup jobs · Remote jobs · San Francisco Bay Area