Director, Regulatory Strategy

Role Summary

Director, Regulatory Strategy. Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly and proactively with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.

Responsibilities

• Interact directly with regulatory authorities.
• Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
• Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
• Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
• Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
• Coordinate, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
• Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Lead multiple assets and/or studies as assigned.
• Liaise internally with members of Exelixis‚Äô functional departments.
• Liaise externally with vendors, licensors, consultants, and joint development collaborators.

Supervisory Responsibilities

• Directly supervise employees.

Education/Experience

• Bachelor‚Äôs degree in related discipline and a minimum of thirteen years of related experience; or,
• Master‚Äôs degree in related discipline and a minimum of eleven years of related experience; or,
• PhD degree in related discipline and a minimum of eight years of related experience; or,
• Equivalent combination of education and experience.

Knowledge/Skills

• Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.
• Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues.
• Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
• Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.
• Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analysing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
• Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.

Job Complexity

• Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
• Plans and executes multiple activities.
• Considers alternative methods and contingency plans to avoid potential issues.
• Designs and implements solutions to address project level challenges, taking into consideration the broader impact.

Working Conditions

• Travel approximately 15%