Senior Director, Regulatory Affairs Strategy

Syndax Pharmaceuticals is looking for a Senior Director, Regulatory Affairs Strategy

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

The Senior Director, Regulatory Affairs 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.

Key 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.

 Desired Experience/Education and Personal Attributes: 

• Bachelor’s degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D, MD).
• Regulatory Affairs Certification highly desirable.
• 10+ years pharmaceutical industry experience, including 8+ 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, 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 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.
• Experience working within corporate partnerships is a plus.
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.

Location: Syndax has offices in Waltham, MA and New York City.

About Syndax:
Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib a highly selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment for both revumenib and Niktimvo. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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