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Braveheart Bio
San Francisco, CA or Remote or Hybrid
Source: Braveheart Bio careers · View original posting
From Braveheart Bio's posting. “We” and “our” refer to the employer.
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 Manager, Regulatory Affairs will play a key role in Braveheart Bio’s global regulatory submissions, spanning U.S. IND and NDA activities and ex-U.S. CTA and MAA activities. Reporting to the Vice President of Regulatory Affairs, this individual will prepare and manage submissions to global health authorities and help develop and execute regulatory strategy. The role requires strong knowledge of U.S.
FDA regulations (21 CFR Parts 312 and 314), the EU Clinical Trials Regulation (EU CTR 536/2014), and hands-on experience navigating country-specific requirements in regions outside the U.S.
This is an exciting opportunity to join the regulatory function at a pivotal stage in Braveheart’s development and make a direct impact on the company’s path to global development. The ideal candidate brings strong knowledge of U.S. and EU regulatory frameworks, experience with U.S. INDs and ex-U.S. CTAs, and the ability to operate in a fast-paced, lean biotech environment.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
Braveheart participates in the federal E
‑
Verify program to confirm employment authorization for all new hires.
To learn more about E-Verify please review this poster.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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