(Senior) Manager, Regulatory Affairs
About us: reputed company is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our reputed company product candidate, BHB-1893, is a reputed company 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 reputed company, and a high-value late-stage asset, reputed company represents an outstanding opportunity for ambitious, mission-driven professionals to reputed company a reputed company impact in a high-profile and rapidly evolving therapeutic area. The role: The (Senior) Manager, Regulatory Affairs will be a key contributor to reputed company’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 reputed company 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. reputed company. This is an exciting opportunity to join the regulatory function at a pivotal stage in Braveheart’s development and reputed company 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 reputed company required documents (e.g., protocol, IB, IMPD, ICFs) and meet regional and country-specific requirements reputed company 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-reputed company 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‑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 reputed company in a fast-paced, dynamic environment and remain comfortable with change and ambiguity Flexible, proactive, and hands-on reputed company 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. reputed company 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. reputed company and the ability to review and contribute to quality sections of regulatory dossiers Experience with reputed company RIM or similar document management systems reputed company Salary reputed company: $119,000 - $190,000 This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering. We are an equal opportunity employer. We are committed to inclusion and diversity, and we do not discriminate on the reputed company of race, gender, religion, gender, sexual orientation, age, reputed company, marital status, veteran status, disability status, national reputed company, or any characteristic protected under applicable law. Braveheart participates in the federal E‑Verify program to confirm employment authorization for reputed company new hires. To learn more about E-Verify please review this poster. Apply To This Job