Remote Associate Director, Regulatory Strategy – Oncology

Syndax Pharmaceuticals; New York (NY); On-site; USD 195,000 - 220,000; Full time

Benefits offered by this job

Equity offering

Annual target bonuses

Outstanding benefits package

Job summary

Syndax Pharmaceuticals is seeking an Associate Director, Regulatory Strategy to develop and implement global regulatory strategies for assigned products, leading regulatory submission efforts and interfacing with health authorities such as the FDA. This remote role supports global development from pre-FIH through lifecycle management.

The candidate will drive strategic regulatory planning, manage teams, and collaborate across functions to ensure compliant, timely filings and submissions across

Qualifications

• Bachelor's degree in scientific discipline; advanced degree preferred (PharmD, Ph.D, MD).
• Regulatory Affairs Certification is highly desirable.
• 8+ years pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles; Global experience desired.
• Experience interfacing with health authorities in major markets.
• Experience in rare disease, immunology or oncology is highly desirable.

Responsibilities

• Ensure the development and flawless execution of regulatory strategies for the assigned products/projects.
• Strategic partner for internal cross functional stakeholders both within and external to the regulatory organization.
• Represents Syndax to regulatory health authorities, e.g. FDA, for all products and businesses.
• Lead the preparation of submissions, including INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications; lead regulatory submission teams.
• Prepare company team for health agency meetings, as required.
• Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
• Maintain knowledge of the global regulatory environment and implications for global strategy.
• Prepare, plan and implement new processes and policies to improve efficiency.

Job description

Syndax Pharmaceuticals is seeking an Associate Director, Regulatory Strategy to develop and implement global regulatory strategies for assigned products, leading regulatory submission efforts and interfacing with health authorities such as the FDA. This remote role supports global development from pre-FIH through lifecycle management.

The candidate will drive strategic regulatory planning, manage teams, and collaborate across functions to ensure compliant, timely filings and submissions across