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About the Role

The Associate Director, Regulatory Strategy will develop and implement global regulatory strategies for assigned products, lead regulatory sub-teams, and serve as a key interface with health authorities and internal stakeholders. This role manages assets through all development phases and may lead a team of regulatory professionals.

Responsibilities

• Ensure the development and flawless execution of regulatory strategies for assigned products/projects.
• Act as a strategic partner for internal cross-functional stakeholders.
• Represent Syndax to regulatory health authorities, such as the FDA.
• Lead the preparation of submissions including INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications.
• Work with cross-functional groups to define contributions to submissions.
• Lead regulatory submission teams for assigned projects.
• Prepare company teams for health agency meetings.
• Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
• Maintain a working knowledge of the global regulatory environment in relevant disease areas and communicate implications of regulatory trends.
• Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and guidance.
• Prepare, plan, and implement new processes and policies to improve company efficiency.

Requirements

• Requires innovator drug development experience in the US and EU/UK/EEA.
• Experience in Asia PAC is a plus.
• Proven 5+ years in a strategic leadership role with strong project management skills.
• Experience working in a complex and matrix environment.
• Experience directly interfacing with health authorities in a major market.
• Experience in multiple phases of development is required.
• Experience in rare disease, immunology or oncology is highly desirable.
• Knowledge of the drug development process and global submission process.
• Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
• Cross-functional partnering skills, team-oriented, and ability to influence outcomes are necessary.
• Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
• Experience working within corporate partnerships is a plus.
• Must be able to innovate, analyze, and solve problems with minimal supervision and attention to detail.

Skills

• Regulatory Strategy
• Project Management
• Drug Development
• Global Submission Process
• Regulatory Guidance
• Cross-functional Partnering
• Team-Oriented
• Influence Outcomes
• Organizational Skills
• Communication Skills
• Time Management Skills
• Innovation
• Problem Solving
• Attention to Detail

Location

• New York, NY
• Remote

Work Type

• Remote

Experience Level

• 8+ years pharmaceutical industry experience
• 5+ years in Regulatory Affairs leadership roles
• 5+ years in a strategic leadership role

Education Level

• Bachelor’s degree in scientific discipline
• Advanced scientific degree preferred (PharmD, Ph.D, MD)
• Regulatory Affairs Certification is highly desirable

Salary/Compensations

• $195,000 - $220,000

Benefits

• Total compensation and rewards package
• Equity offering
• Annual target bonuses
• Outstanding benefits program

About the Company

• Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies.
• Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease.
• Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment.
• For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Equal Opportunity

• 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.