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-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 dossiers
- Experience with Veeva RIM or similar document management systems
Base Salary Range: $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.
