Remote Executive Director, Regulatory Strategy

Syndax Pharmaceuticals is looking for an Executive Director, Regulatory Strategy

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

The Executive Director, Regulatory Strategy will be responsible for developing and implementing regulatory strategies to secure global investigational and marketing applications for assigned product(s) in the assigned therapeutic area.  Ensures strategic messaging and content of global regulatory dossiers. Is expected to serve as the primary regulatory interface with the Asset Strategy Team.  Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements.  Manages assets through all phases of development from pre-FIH through active life cycle management development.  The role is expected to drive regulatory acceleration strategies, innovative regulatory strategies, analyzing regulatory precedence and operational excellence in execution of regulatory strategy. This role will lead a small team of regulatory strategists.

Key Responsibilities:

• Provide regulatory strategic leadership to Asset Strategy Teams for the development and life cycle management (LCM) of assigned products, including but not limited to global regulatory strategy, operational submission strategy, health authority interactions strategy, and other regulatory requirements in line with corporate objectives and timelines.
• Collaborate with senior stakeholders across functions to align regulatory strategies with business goals.
• Accountable for value added regulatory health authority interactions and the development of innovative regulatory strategies.
• Accountable to concisely articulate regulatory risks and develop mitigation strategies whilst identifying opportunities to accelerate development in a fast-paced, dynamic environment.
• Provide leadership, direction, and contribute hands-on to the regulatory team in managing, planning, coordinating, and preparing regulatory documentation.
• Lead and mentor a team of regulatory strategists, focusing on staff development.
• Monitor and assess the global regulatory landscape to inform business and product development strategies.
• Accountable for actively maintaining a contemporary working knowledge of the global regulatory environment in relevant disease areas and identify and communicate the implications of identified regulatory trends that may impact the business.

Desired Experience/Education and Personal Attributes:

• Bachelor’s degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D, MD).
• 15+ years pharmaceutical industry experience, including 10+ years in Regulatory Affairs strategy roles with proven 5+ years in a strategic leadership role.
• Requires a demonstrated proficiency in developing and executing global regulatory strategy with extensive demonstrated experience in the US.
• Experience effectively leading in a complex and matrix environment.
• Experience directly interfacing with health authorities in multiple major global markets.
• Demonstrated experience in oncology highly desirable.
• Direct experience in late phase drug development, global submission processes and life cycle strategies.
• Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy.
• Cross functional partnering skills, team-oriented and ability to drive outcomes are necessary skills in the environment.
• Strong business acumen and strategic thinking capabilities, able to navigate complex challenges and contribute to the business’s long-term vision.
• Must be solution oriented with demonstrated skills to innovate, analyze, solve problems, and foster a collaborative working environment.
• Excellent communication skills, with the ability to articulate complex issues clearly and persuasively to a diverse stakeholder group.
• Ability to travel up to 10 %.

Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States.

About Syndax:

Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company’s pipeline include revumenib a highly selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment for both revumenib and Niktimvo. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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