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About the Role

The Senior Manager, Regulatory Affairs will play a key role in global regulatory submissions, spanning U.S. IND and NDA activities and ex-U.S. CTA and MAA activities. 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 and the EU Clinical Trials Regulation, with hands-on experience navigating country-specific requirements 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.

Responsibilities

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
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 and input to pre-NDA meeting packages
Track U.S. submission status and maintain inspection-ready documentation and regulatory archives
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 and meet regional and country-specific requirements
Provide regulatory guidance on EU CTIS and country-specific CTA processes and requirements
Manage health authority questions 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
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 to ensure quality and on-time delivery
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

Requirements

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
Advanced degree (MS, PhD, PharmD) is preferred
Experience with regulatory submissions in ex-U.S. regions such as the UK (MHRA), Canada (Health Canada), Australia (TGA), South Korea (MFDS), or LATAM is preferred
Experience supporting the preparation of marketing applications (e.g., NDAs and MAAs) is preferred
Experience in cardiovascular, rare disease, or small molecule drug development is preferred
Familiarity with CMC regulatory requirements in ex-U.S. regions and the ability to review and contribute to quality sections of regulatory dossiers is preferred
Experience with Veeva RIM or similar document management systems is preferred

Skills

U.S. IND submissions
EU CTA submissions in CTIS
Ex-U.S. CTA preparation and coordination
Health authority interactions and response management
U.S. FDA regulations (21 CFR Parts 312 and 314)
EU regulatory frameworks (EU CTR 536/2014)
EMA guidance and CTA requirements
ICH guidelines
IND and CTA lifecycle management
Project management
Organizational skills
Independent work
Managing multiple priorities
Meeting deadlines
Clear and accurate regulatory document writing
Detail-orientation
Quality and compliance commitment
Written communication
Verbal communication
Collaborative approach
Team-oriented approach
Adaptability to fast-paced, dynamic environments
Comfort with change and ambiguity
Flexibility
Proactive mindset
Hands-on mindset
CMC regulatory requirements
Veeva RIM or similar document management systems

Experience Level

Minimum of 7 years of regulatory affairs experience

Education Level

Bachelor’s degree
Advanced degree (MS, PhD, PharmD) is preferred

Salary/Compensations

$170,000 - $195,000

Benefits

Competitive total rewards package
Annual bonus
Equity
Comprehensive benefits offering

About the Company

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.

Equal Opportunity

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.