Braveheart Bio

Braveheart Bio

(Senior) Manager, Regulatory Affairs

San Francisco, CA or Remote or Hybrid · Senior

Sponsorship not specified$119k-$190kDetected 15 days ago
Project ManagementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationOrganizational SkillsRegulatory Affairs

About 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.
  • 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.

Responsibilities

  • Manage the preparation, compilation, and submission of CTAs, including CTIS submissions and country-specific applications
  • Track submission status and maintain inspection-ready documentation and regulatory archives
  • 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

Requirements

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

Skills

  • Bachelor's degree
  • 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)
  • 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
  • Advanced degree (MS, PhD, PharmD)
  • Experience supporting the preparation of marketing applications (e.g., NDAs and MAAs)
  • Preferred experience &
  • Experience in cardiovascular, rare disease, or small molecule drug development

Compensation

  • This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.
  • $119,000 - $190,000
  • Support CTA maintenance activities, including substantial modifications, protocol amendments, IMPD updates, quality changes, annual updates, and notifications

Benefits

  • Manage health authority questions and sponsor responses to support timely approvals

Company info

  • 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.
  • 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.
  • 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.

Equal opportunity

  • We are an equal opportunity employer.

Visa & Work Authorization

  • Manage health authority questions and sponsor responses to support timely approvals
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This listing is sourced directly from Braveheart Bio's careers page and normalized into a canonical job model.