Executive Director, Regulatory Strategy

SUMMARY/JOB PURPOSE:

The Executive Director, Regulatory Affairs has oversight for all regulatory activities for new development programs, pre-IND through BLA/NDA and post-approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Additionally, s/he provides expertise in translating regulatory requirements into practical, workable plans. Develops and implements strategies for earliest possible approvals of phase 1 through phase 4 applications. Provides counsel to and manages the clinical regulatory team. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies.

Essential Duties And Responsibilities:

• Oversight and management of Regulatory Program Leaders and their staff.

• Oversee the development of plans incorporating regulatory strategies designed to maximize chances of successful registration.

• Understand policies, key personnel, and regulatory climate at the FDA and maintain a good working relationship with the FDA.

• Oversight of documents submitted to regulatory agencies to assure that they are complete, well organized, are of high-quality, are in regulatory compliance, and are presented in a way that facilitates agency review.

• Address regulatory agency requirements to pursue approval of additional clinical indications and new dosage forms.

• Manage clinical development program planning to anticipate changes in regulatory environment and approval requirements.

• Oversee Exelixis interactions with Health Authorities. Ensure there is to expedient and efficient review and approval of submissions by the regulatory program teams.

• Ensure the preparation and submission of INDs, NDAs, BLAs, reports and correspondence to regulatory agencies are completed by the team according to Exelixis best practice and of high quality.

• Manage the planning and implementation of meetings with regulatory agencies.

• Coordinate the completion of adverse reaction reports and follow-up safety reports to ensure completeness and submission to regulatory agencies within the established regulatory timelines.

• Assist in monitoring current and proposed regulatory, scientific, and pertinent legal issues and advise management on events of significance for Exelixis’ business interests.

• Critically review nonclinical, chemistry, manufacturing and controls, and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with health authority regulations and guidance.

• Provide regulatory strategic guidance on documents and submission plans to align with study and company objectives.

• Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency commensurate with departmental growth.

• Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.

• Liaise internally with members of Exelixis’ functional departments.

• Liaise externally with vendors, licensors, and joint development collaborators.

• Maintain collaboration and healthy discourse among the team in line with Exelixis leadership competencies.

• Develop staff and ensure documentation of individual development plans

Supervisory Responsibilities:

• Provide direction to other individuals.

• Supervises staff, including hiring, scheduling, and assigning work, and reviewing performance.

• Manages others through subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 18 years of related experience; or,

• MS/MA degree in related discipline and a minimum of 16 years of related experience; or,

• PhD in related discipline and a minimum of 15 years of related experience; or,

• Equivalent combination of education and experience.

• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Minimum 18 years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training

• Minimum nine years regulatory experience in a position o