The role:The Senior Manager, Regulatory Affairs will play a key role in Braveheart Bio's global regulatory submissions, spanning U.S. IND and NDA activities and ex-U.S. CTA and MAA activities. Reporting to the Vice President of Regulatory Affairs, this individual will prepare and manage submissions to global health authorities and help develop and execute regulatory strategy. The role requires strong knowledge of U.S. FDA regulations (21 CFR Parts 312 and 314), the EU Clinical Trials Regulation (EU CTR 536/2014), and hands-on experience navigating country-specific requirements in regions outside the U.S.
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 strong knowledge of U.S. and EU regulatory frameworks, experience with U.S. INDs and ex-U.S. CTAs, and the ability to operate in a fast-paced, lean biotech environment.
Key responsibilities:U.S. IND and NDA Preparation, Execution, and Life-cycle Management- Manage the preparation and coordination of submissions to INDs
- Ensure IND submissions include all required documents and meet FDA requirements
- Provide regulatory guidance on U.S. IND processes and requirements, including FDA meeting requests and briefing packages
- Manage FDA information requests and sponsor responses to support timely submissions to meet deadlines, where applicable
- Support preparation for FDA regulatory interactions and IND maintenance activities, including protocol amendments, information amendments, CMC changes, safety reports, annual reports, and other notifications
- Support preparation of NDA submissions, including coordination of module content (e.g., financial disclosures, BIMO), as well as input to pre-NDA meeting packages
- Track U.S. submission status and maintain inspection-ready documentation and regulatory archives
Ex-U.S. CTA and MAA Preparation, Execution, and Lifecycle Management- Manage the preparation, compilation, and submission of CTAs, including EU CTIS submissions and country-specific applications in regions outside the U.S.
- 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 CTIS and country-specific CTA processes and requirements
- Manage health authority questions (e.g., requests for information) and sponsor responses to support timely approvals
- Support CTA maintenance activities, including substantial modifications, IMPD updates, quality changes, annual updates, and notifications
- Support preparation of MAAs and other ex-U.S. marketing applications
- Track ex-U.S. submission status and maintain inspection-ready documentation and regulatory archives
Regulatory Strategy and Vendor Oversight- Contribute to the development and execution of global regulatory strategy, including health authority engagement plans and submission timelines
- Monitor evolving U.S., EU, and ex-U.S. regulatory requirements and guidance, and assess the impact on development plans
- Oversee regulatory vendors (e.g., publishing and regional regulatory service providers) to ensure quality and on-time delivery
Cross-Functional Collaboration- Serve as a regulatory liaison across internal teams and external partners to ensure timely and compliant submissions
- 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 IND, IMPD, and quality documentation
Required experience & skills:- Bachelor's degree
- Minimum of 7 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on U.S., EU, and ex-U.S. clinical trial submissions
- Demonstrated hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, ex-U.S. CTA preparation and coordination, and health authority interactions and response management
- Strong knowledge of U.S. FDA regulations (including 21 CFR Parts 312 and 314), EU regulatory frameworks (including EU CTR 536/2014), EMA guidance and CTA requirements, and applicable ICH guidelines
- Experience managing IND and CTA lifecycle activities (amendments, updates, and maintenance)
- Strong project management and organizational skills, with the 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 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: $170,000 - $195,000
This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.
