(Senior) Manager, Regulatory Affairs

Das ist der Job

Clinical Trial Application (CTA) planning and execution.

Darum lohnt es sich

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.

CTA Preparation, Execution, and Life‑cycle Management Manage the preparation, compilation, and submission of CTAs, includingCTIS submissionsand country‑specific applications Ensure CTA packages include all required documents (e.g., protocol, IB, IMPD, ICFs) and meetregional and country‑specific requirements Provide regulatory guidance onEU CTR, CTIS processes, and country‑specific CTA requirements Managehealth authority questions and sponsor responsesto support timely approvals Support CTAmaintenance activities, including substantial modifications, protocol amendments, IMPD updates, quality changes, annual updates, and notifications Track submission status and maintaininspection‑ready documentation and regulatory archives Cross‑Functional Collaboration Partner closely withClinical Development and Clinical Operationsto support global study start‑up timelines Collaborate withCMC and Quality teamsto 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 onEU 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 managingCTA 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 dossiers Experience with Veeva RIM or similar document management systems Base Salary Range: $119,000 - $190,000 Additional information: This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

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.

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.

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 navigatingcountry‑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. We 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.

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. #J-18808-Ljbffr