Job Description

ABOUT THE COMPANY:

Quetzal Therapeutics is dedicated to transforming the future of medicine by addressing unmet medical needs in oncology and rare diseases. Through cutting-edge science and pioneering innovation, we develop breakthrough therapies that improve patients' lives. Our mission is to push the boundaries of treatment possibilities, delivering hope and life-changing solutions to those who need them most.

Quetzal Therapeutics is a biopharmaceutical company focused on the development of treatment for hematologic malignancies. The company’s lead product is QTX-2101, a novel paradigm for treating patients with AML/APL. The company plans to initiate Phase III clinical trials by late-2025, with registration-enabling activities ongoing. Quetzal is also developing a pre-clinical asset QTX 2102, an advanced, next-generation antifungal and antiparasitic therapy designed to enhance efficacy while minimizing toxicity. By leveraging improved formulations and targeted delivery, this novel treatment aims to overcome the limitations of conventional therapy, offering a safer and more effective solution for life-threatening infections. We are in active portfolio expansion mode with additional programs being introduced into development.

SUMMARY OF ROLE:

The Executive Director / Vice President, Regulatory Sciences will serve as a strategic partner and senior leader within Quetzal Therapeutics, responsible for developing and executing global regulatory strategies to support the registration and lifecycle management of our novel small molecule programs. This individual will lead regulatory interactions with the FDA, EMA, and other health authorities, and will play a central role in driving the successful preparation and submission of NDAs/MAAs for new chemical entities (NCEs).

The ideal candidate has deep expertise in small molecule drug development, hands-on experience with regulatory filings for NCE approvals, and a proven track record of successfully navigating complex global regulatory environments.

Key Responsibilities

Strategic Leadership

• Define and lead global regulatory strategy across all development stages (pre-IND, IND, NDA, MAA, post-approval).
• Drive preparation and submission of INDs, Annual Reports, DSURs, CTA/IMPDs, and global equivalents.
• Lead FDA (Pre-IND, IND, End-of-Phase II, Pre-NDA) and EMA (Scientific Advice, CHMP) meetings with special emphasis on clinical trial design, endpoints, statistical plans, and risk/benefit assessments.
• Provide regulatory input into clinical study protocols, development plans, patient recruitment strategies, and labeling considerations.
• Oversee clinical regulatory strategy and execution, ensuring clinical development plans are aligned with regulatory expectations and timelines.
• Serve as the regulatory subject matter expert and advisor to the CEO, Executive Team, and Board of Directors.
• Anticipate and interpret regulatory trends, guidelines, and policy changes affecting small molecule development.

Regulatory Submissions & Approvals

• Oversee preparation and submission of NDAs/MAAs for new chemical entities, ensuring clinical, CMC, and nonclinical modules are scientifically sound and compliant.
• Anticipate and proactively mitigate regulatory risks, ensuring timely resolution of health authority questions.
• Ensure submissions meet global standards and withstand rigorous scientific and regulatory scrutiny.

CMC & Cross-Functional Integration

• Partner with CMC teams to align regulatory strategy with manufacturing, formulation, and quality requirements; CMC regulatory management experience is a strong asset.
• Integrate CMC, nonclinical, and clinical development activities into a unified regulatory plan.
• Provide regulatory perspectives in product lifecycle management, including labeling, post-marketing studies, and line extensions.

Leadership & Team Development

• Build and lead a high-caliber regulatory team, including clinical and CMC regulatory specialists.
• Manage outside consultants, CROs, and global regulatory partners to deliver submission excellence.
• Serve as an executive leader representing regulatory affairs at Board meetings, investor presentations, and partnerships.

Qualifications & Requirements

• Advanced degree in Life Sciences (PharmD, PhD, MD, or equivalent).
• 15+ years of regulatory affairs experience in the biopharma industry.
• Proven success leading clinical regulatory strategies in small molecule development, from early development through NDA/MAA approval.
• Direct, hands-on leadership of at least one successful NCE regulatory submission (NDA/MAA) is required.
• Robust understanding of FDA, EMA, and ICH clinical regulatory frameworks.
• Experience in writing, reviewing, and negotiating critical clinical regulatory documents.
• CMC regulatory experience is highly desirable, particularly IND/NDA Module 3 strategy and review.
• Demonstrated executive presence with ability to effectively interface with global regulatory authorities, senior management, and Boards.
• Proven success leading regulatory activities from preclinical through late-stage/commercial programs, including change controls, post-approval compliance, and life-cycle management.
• Strong business acumen and the ability to manage priorities, deadlines, and competing demands within a small, dynamic organizational setting.
• Outstanding communication—verbal, written, and presentation—skills with the ability to influence, negotiate, and drive consensus across multiple levels.

Key Competencies

• Clinical regulatory expertise with an integrated understanding of development strategy.
• Strong operational execution combined with big-picture strategy.
• Confidence to lead regulatory interactions independently and decisively.
• Collaborative leader who can partner effectively across clinical, CMC, and nonclinical teams.
• High integrity, rigor, and commitment to patient-centric innovation.

POSITION: Full-Time, Exempt, Flexibility for Remote Work

Reports to : Chief Scientific Officer/ Chief Medical Officer

Why Join Quetzal?

This role provides an exceptional opportunity for an experienced and visionary regulatory leader to shape the future of innovative therapies at a nimble, growth-oriented biotech company. The position offers broad exposure to all aspects of CMC and clinical development, enabling significant strategic and operational impact across the product lifecycle.

DISCLAIMER: The list under Role Responsibilities is not exhaustive but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.

EEO Statement: Quetzal is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation.

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