Associate Director, Regulatory Strategy
Syndax Pharmaceuticals
August 24, 2026
Remote
United States
Corporate Functions
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.
Key Responsibilities:
- Ensure development and flawless execution of regulatory strategies for assigned products/projects.
- Partner with internal cross-functional stakeholders within and outside regulatory.
- Represent the company to regulatory health authorities (e.g., FDA) for all products and businesses.
- Lead preparation of submissions (e.g., INDs, briefing documents, orphan drug applications, marketing applications); coordinate cross-functional contributions; lead submission teams.
- Prepare internal teams for health agency meetings (as required).
- Serve as primary interface with Regulatory CROs for submission coordination and preparation.
- Maintain working knowledge of global regulatory environment and communicate implications of regulatory trends.
- Maintain knowledge of global competitive landscape, regulations, and guidance.
- Prepare, plan, and implement new processes/policies to improve company efficiency.
Desired Experience/Education and Personal Attributes:
- Bachelor’s degree in scientific discipline; advanced degree preferred (PharmD, Ph.D, MD).
- Regulatory Affairs Certification highly desirable.
- 8+ years pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles; global experience desired.
- Innovator drug development experience in US and EU/UK/EEA; Asia PAC experience a plus.
- 5+ years in strategic leadership with strong project management.
- Experience in complex/matrix environments; directly interfacing with health authorities in a major market.
- Experience across multiple phases of development (required).
- Rare disease, immunology, or oncology experience highly desirable.
- Knowledge of drug development process and global submission process; global regulatory guidance.
- Strong cross-functional partnering skills; excellent organization/communication/time management.
- Ability to innovate, analyze, and solve problems with minimal supervision; attention to detail.
- Corporate partnerships experience a plus.
Key Responsibilities:
- Ensure development and flawless execution of regulatory strategies for assigned products/projects.
- Partner with internal cross-functional stakeholders within and outside regulatory.
- Represent the company to regulatory health authorities (e.g., FDA) for all products and businesses.
- Lead preparation of submissions (e.g., INDs, briefing documents, orphan drug applications, marketing applications); coordinate cross-functional contributions; lead submission teams.
- Prepare internal teams for health agency meetings (as required).
- Serve as primary interface with Regulatory CROs for submission coordination and preparation.
- Maintain working knowledge of global regulatory environment and communicate implications of regulatory trends.
- Maintain knowledge of global competitive landscape, regulations, and guidance.
- Prepare, plan, and implement new processes/policies to improve company efficiency.
Desired Experience/Education and Personal Attributes:
- Bachelor’s degree in scientific discipline; advanced degree preferred (PharmD, Ph.D, MD).
- Regulatory Affairs Certification highly desirable.
- 8+ years pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles; global experience desired.
- Innovator drug development experience in US and EU/UK/EEA; Asia PAC experience a plus.
- 5+ years in strategic leadership with strong project management.
- Experience in complex/matrix environments; directly interfacing with health authorities in a major market.
- Experience across multiple phases of development (required).
- Rare disease, immunology, or oncology experience highly desirable.
- Knowledge of drug development process and global submission process; global regulatory guidance.
- Strong cross-functional partnering skills; excellent organization/communication/time management.
- Ability to innovate, analyze, and solve problems with minimal supervision; attention to detail.
- Corporate partnerships experience a plus.