About us: 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. S. Clinical Trial Application (CTA) planning and execution.

Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross‑functional deliverables and manage health authority queries and responses. S. , New Drug Applications and Marketing Authorisation Applications).

Requirements

S. regions. 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.

S. CTAs, and the ability to operate in a fast-paced, lean biotech environment.

Provide regulatory guidance on EU CTR, CTIS processes, and country-specific CTA

S. S.

, and applicable ICH guidelines Experience managing CTA lifecycle activities (amendments, updates, and maintenance) Strong project management and organizational skills, with ability to work independently, manage multiple priorities, and meet deadlines in a lean, fast-paced e

Key Responsibilities

(Senior) Manager, Regulatory Affairs