(Senior) Manager, Regulatory Affairs

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.

The role:

The (Senior) Manager, Regulatory Affairs will be a key contributor to Braveheart Bio’s global regulatory submissions, with a primary focus on European Union (EU) and ex-U.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. This individual may also provide support to the U.S. IND applications and contribute to the preparation of marketing applications (e.g., New Drug Applications and Marketing Authorisation Applications). The role requires deep familiarity with EU Clinical Trials Regulation (EU CTR 536/2014) and practical experience navigating country‑specific requirements across ex‑U.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. The ideal candidate brings deep knowledge of EU regulatory frameworks, experience with ex-U.S. CTAs, and the ability to operate in a fast-paced, lean biotech environment.

Key responsibilities:

EU and Ex-U.S. CTA Preparation, Execution, and Life-cycle Management

Manage the preparation, compilation, and submission of CTAs, including CTIS submissions and country-specific applications

Ensure CTA packages include all required documents (e.g., protocol, IB, IMPD, ICFs) and meet regional and country-specific requirements

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

Manage health authority questions and sponsor responses to support timely approvals

Support CTA maintenance activities, including substantial modifications, protocol amendments, IMPD updates, quality changes, annual updates, and notifications

Track submission status and maintain inspection-ready documentation and regulatory archives

Cross-Functional Collaboration

Partner closely with Clinical Development and Clinical Operations to support global study start-up timelines

Collaborate with CMC and Quality teams to ensure accurate and compliant IMPD and quality documentation

Serve as a regulatory liaison across internal teams and external partners to ensure timely and compliant submissions across ex‑U.S. markets

Required experience skills:

Bachelor’s degree

Minimum of 5 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on EU and ex‑U.S. clinical trial submissions

Demonstrated hands-on experience with EU CTA submissions in CTIS, CTA preparation and coordination, health authority interactions and response management

Strong knowledge of EU regulatory frameworks including EU CTR 536/2014, EMA guidance and CTA requirements, 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 environment

Demonstrated ability to write clear, accurate regulatory documents

Detail-oriented with a commitment to quality and compliance

Strong written and verbal communication skills with a collaborative, team-oriented approach

Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity

Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience skills:

Advanced degree (MS, PhD, PharmD)

Experience with regulatory submissions in the U.S. (FDA) and other ex-U.S. regions such as the UK (MHRA), Canada (Health Canada), Australia (TGA), South Korea (MFDS), or LATAM

Experience supporting the preparation of marketing applications (e.g., NDAs and MAAs)

Experience in cardiovascular, rare disease, or small molecule drug development

Familiarity with CMC regulatory requirements in ex-U.S. regions and the ability to review and contribute to quality sections of regulatory do…