Director, Regulatory Strategy

Syndax Pharmaceuticals • New York, NY

23h • Remote

About The Position

Syndax Pharmaceuticals is a commercial stage biopharmaceutical company focused on developing innovative cancer therapies, with a mission to enable people with cancer to live longer and better. The Director, Regulatory Strategy will be responsible for developing and implementing global regulatory strategies for investigational and marketing applications for assigned products within a specific therapeutic area. This role involves leading the Product Regulatory Sub team, ensuring strategic messaging and content for global regulatory dossiers, and potentially serving as the primary regulatory interface with the Asset Strategy Team and sub teams. The Director will proactively anticipate and mitigate regulatory risks, ensure compliance with global regulatory requirements, and manage assets through all phases of development from pre-FIH to active life cycle management. The position requires a strong understanding of drug development, leadership behaviors, and direct experience with regulatory acceleration strategies, regulatory strategy development, regulatory precedence analysis, and operational excellence in execution. The role may also involve leading a team of regulatory professionals.

Requirements

• Bachelor’s degree in scientific discipline
• 8+ years pharmaceutical industry experience
• 5+ years in Regulatory Affairs leadership roles
• 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

• Advanced scientific degree preferred (PharmD, Ph.D, MD)
• Regulatory Affairs Certification is highly desirable
• Global experience desired
• 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

• Total compensation and rewards package that is among the most competitive in the industry
• Base pay determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity
• Equity offering
• Annual target bonuses
• Outstanding benefits program

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees