Director, Regulatory Strategy
About The Position
The 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. 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. Manages assets through all phases of development from pre-FIH through active life cycle management activities. Demonstrates an understanding of drug development and exhibits leadership behaviors consistent with level. Has direct experience with regulatory acceleration strategies, developing regulatory strategy, analyzing regulatory precedence and operational excellence in execution of regulatory strategy. This role may lead a team of regulatory professionals.
Requirements
- Bachelor’s degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D, MD).
- 8+ years 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.
- 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.
- 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 skills in the environment.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
Nice To Haves
- Regulatory Affairs Certification is highly desirable.
- Experience in Asia PAC, a plus.
- Experience in rare disease, immunology or oncology is highly desirable.
- Experience working within corporate partnerships is a plus.
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, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
- Work with cross-functional groups to define contributions to submissions.
- Lead regulatory submission teams for projects assigned.
- Prepare company team for health agency meetings, as required.
- Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
- Responsible for maintaining a working knowledge of the global regulatory environment in relevant disease areas and identify and communicate the implications of identified regulatory trends that may impact the business.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance.
- Prepare, plan and implement new processes and policies to improve efficiency of the Company.
Benefits
- equity offering
- annual target bonuses
- outstanding benefits program
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What This Job Offers
Job Type
Full-time
Career Level
Director
