Hybrid Director, Regulatory Strategy chez Syndax pharmaceuticals

Syndax Pharmaceuticals is looking for a Director, Regulatory 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 commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

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.  May lead the Regulatory Sub-team for assigned products.  Ensures aligned strategic messaging and content of global regulatory dossiers. May serve as the primary regulatory interface with the Asset Strategy 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.

Key Responsibilities:

• Ensure the development and flawless execution of regulatory strategies for the assigned 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 assigned projects and/or indications.
• 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. Partner with a regulatory project manager to lead regulatory submission teams for assigned projects.
• Prepare company team for health agency meetings, as required.
• Serve as the primary interface with Regulatory CROs for coordination and preparation of investigational application 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 guidelines.
• 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).
• 10+ years pharmaceutical industry experience, including 7+ years in Regulatory Affairs strategy roles with strong project management skills.
• Requires innovator clinical drug development experience in the US.  Experience in EU, UK or Asia PAC, a plus. 
• Experience working in a complex and matrix environment. 
• Experience directly interfacing with health authorities in the US or EU.
• Experience in multiple phases of development is required.
• Experience in oncology is highly desirable.
• Knowledge of the drug development process and global submission process.
• Knowledge of global regulatory guidelines 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.

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $220,000 - $250,000.

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. 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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