Associate Director, Regulatory Strategy

About the Role

The Associate 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. Leads the Product Regulatory Sub team and ensures strategic messaging and content of global regulatory dossiers. May serve as the primary regulatory interface with the Asset Strategy Team and sub teams. Proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages assets through all phases of development from pre-FIH through active life cycle management activities.

Responsibilities

• Ensure the development and flawless execution of regulatory strategies for the assigned products/projects.
• Serve as a strategic partner for internal cross-functional stakeholders both within and external to the regulatory organization.
• Represent Syndax to regulatory health authorities (e.g., FDA) for all products and businesses.
• Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications.
• Work with cross-functional groups to define contributions to submissions and lead regulatory submission teams for assigned projects.
• Prepare the company team for health agency meetings, as required.
• 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 regulatory trends that may impact the business.
• Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and guidance.
• Prepare, plan, and implement new processes and policies to improve efficiency.

Requirements

• Bachelor’s degree in a scientific discipline; advanced scientific degree preferred (PharmD, Ph.D, MD).
• Regulatory Affairs Certification is highly desirable.
• 8+ years of pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles; global experience desired.
• 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 it relates to overall global regulatory strategy.
• Cross-functional partnering skills, team-oriented, and ability to influence outcomes.
• Excellent organizational, communication, and time management skills to manage multiple ongoing projects simultaneously.
• Experience working within corporate partnerships is a plus.
• Ability to innovate, analyze, and solve problems with minimal supervision and attention to detail.

Benefits

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. The overall package includes an equity offering, annual target bonuses, and an outstanding benefits program.

Pay

The anticipated annualized salary range for this role is $195,000 - $220,000.

About Syndax

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. Syndax is conducting several clinical trials across the continuum of treatment. For more information, visit www.syndax.com or follow the Company on X and LinkedIn.

This is a remote opportunity based at Syndax’s corporate office in New York, NY.