Director, Regulatory Affairs

About us:Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)— the most common inherited cardiac disease.Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation.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 Director of Regulatory Affairs will serve as the Global Regulatory Lead and provide regulatory leadership for Braveheart Bio’s Phase 3 hypertrophic cardiomyopathy (HCM) program. Reporting into the Vice President of Regulatory, Safety & Pharmacovigilance, this individual will be responsible for developing and executing global regulatory strategies to support late-stage clinical development, registration readiness, and lifecycle management for our HCM asset. In addition, this role will support the implementation and optimization of regulatory systems and infrastructure as Braveheart continues to scale.Key responsibilities:Serve as Global Regulatory Lead for the Phase 3 HCM program, leading the development and execution of regulatory strategies that result in successful registration and post-approval commercialization of our HCM assetProvide strategic regulatory input and leadership at program governance forums and core team meetingsProactively identify regulatory risks and develop mitigation strategiesPlan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readinessServe as the primary point of contact with FDA and other health authorities as applicableLead regulatory agency meetings and coordinate the preparation of supporting meeting materialsEnsure the content in regulatory submissions is complete, well-written, and meets all applicable requirements for the program’s development phasePartner with and support Clinical, Nonclinical, CMC, and Safety & Pharmacovigilance activities, including the review and submission clinical protocols, IBs, DSURs throughout the product life cycleEnsure regulatory deliverables, support clinical timelines, quality standards, and compliance expectationsMaintain broad and current knowledge of regulatory requirements and guidelines across clinical, nonclinical, submission, and compliance domainsSupport the implementation of additional systems and process improvements as neededRequired experience & skills:Bachelor’s degree required; advanced degree in life science (MD, PhD, PharmD, or MS) preferredA minimum of 10+ years in regulatory affairs, including serving as Global Regulatory Lead for investigational productsHands-on experience with INDs and/or CTAs and writing regulatory documentsExperience supporting Phase 3 development and late-stage regulatory activitiesExperience leading regulatory agency interactions and meetingsExperience with marketing applications (e.g., NDAs/BLAs, MAAs) and post-approval supplements and variations is preferredDeep familiarity with cardiovascular or rare disease development program is a plusThorough knowledge of US and international regulations as they apply to pharmaceutical drug developmentDemonstrated ability to communicate complex regulatory concepts clearly and effectively across internal and external stakeholdersStrong strategic skills including demonstrated ability to make complex decisions and defend difficult positionsStrong track record of strategic leadership, collaboration, and influence in cross-functional settingsStrong written and verbal communication skills with a collaborative, team-oriented approachAbility to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguityFlexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitudeWe are an equal opportunity employer.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.