Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

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 role involves managing CROs, coordinating cross-functional deliverables, and handling health authority queries. It offers an exciting opportunity to join the regulatory function at a pivotal stage and make a direct impact on the company’s global development path.

Responsibilities

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.
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

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.

Skills

EU CTR 536/2014
CTIS
Project management
Organizational skills
Regulatory document writing
Written communication
Verbal communication
Team collaboration
Veeva RIM or similar document management systems

Location

EU
ex-U.S.

Work Type

Full-time

Experience Level

Manager
Senior Manager

Education Level

Bachelor's degree
MS
PhD
PharmD

Salary/Compensations

$119,000 - $190,000

Benefits

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.