Associate Director, Regulatory Strategy

About the role

Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Associate Director, Regulatory Strategy will develop and implement regulatory strategies for assigned products/projects.

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.
• Represent 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.

Requirements

This role may lead a team of regulatory professionals. Requires 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. Experience in Asia PAC, a plus. Requires 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.

Qualifications

• Bachelor’s degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D, MD).
• Regulatory Affairs Certification is highly desirable.

Skills

• Knowledge of the drug development process and global submission process.
• Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
• Experience in multiple phases of development is required.
• Experience in rare disease, immunology or oncology is highly desirable.
• Experience directly interfacing with health authorities in a major market.
• Experience working within corporate partnerships is a plus.

Benefits

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 $200,000 - $225,000.

Pay

The anticipated annualized salary range for this role is $200,000 - $225,000.

Schedule

This is a remote opportunity.

Contact

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. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.