Associate Director, Regulatory Strategy
Syndax Pharmaceuticals
5 days ago
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 the development and flawless execution of regulatory strategies for assigned products/projects.
- Strategic partner for internal cross-functional stakeholders within and external to regulatory.
- Represents the company to regulatory health authorities (e.g., FDA).
- Lead preparation of submissions (e.g., INDs, Briefing Documents, Orphan Drug Applications, Marketing Applications) and lead submission teams.
- Prepare the company team for health agency meetings, as required.
- Primary interface with Regulatory CROs for coordination and submission preparation.
- Maintain working knowledge of the global regulatory environment and communicate implications of regulatory trends.
- Maintain knowledge of the global competitive landscape, regulations, and guidance.
- Prepare, plan, and implement 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 pharma industry experience, including 5+ years in Regulatory Affairs leadership roles (global experience desired).
- Innovator drug development experience in the US and EU/UK/EEA; Asia PAC experience a plus.
- 5+ years in strategic leadership with strong project management; experience in complex, matrix environments.
- Direct experience interfacing with health authorities in a major market; experience across multiple development phases.
- Rare disease, immunology, or oncology experience highly desirable.
- Knowledge of drug development and global submission processes and global regulatory guidance.
- Strong cross-functional partnering, influence, excellent organization/communication/time management.
- Ability to innovate, analyze, and solve problems with minimal supervision; attention to detail.
Location/Work Model:
- New York, NY (remote opportunity).
Key Responsibilities:
- Ensure the development and flawless execution of regulatory strategies for assigned products/projects.
- Strategic partner for internal cross-functional stakeholders within and external to regulatory.
- Represents the company to regulatory health authorities (e.g., FDA).
- Lead preparation of submissions (e.g., INDs, Briefing Documents, Orphan Drug Applications, Marketing Applications) and lead submission teams.
- Prepare the company team for health agency meetings, as required.
- Primary interface with Regulatory CROs for coordination and submission preparation.
- Maintain working knowledge of the global regulatory environment and communicate implications of regulatory trends.
- Maintain knowledge of the global competitive landscape, regulations, and guidance.
- Prepare, plan, and implement 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 pharma industry experience, including 5+ years in Regulatory Affairs leadership roles (global experience desired).
- Innovator drug development experience in the US and EU/UK/EEA; Asia PAC experience a plus.
- 5+ years in strategic leadership with strong project management; experience in complex, matrix environments.
- Direct experience interfacing with health authorities in a major market; experience across multiple development phases.
- Rare disease, immunology, or oncology experience highly desirable.
- Knowledge of drug development and global submission processes and global regulatory guidance.
- Strong cross-functional partnering, influence, excellent organization/communication/time management.
- Ability to innovate, analyze, and solve problems with minimal supervision; attention to detail.
Location/Work Model:
- New York, NY (remote opportunity).