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 of substantial responsibility.
• Prior experience working with the relevant review divisions at FDA.
• Experience in oncology drug development required.

Knowledge/Skills:

• Has extensive experience in relevant industry/profession.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems. If technical or scientific job, works on unusually complex technical problems and provides solutions which are highly innovative and ingenious.
• Applies advanced practices, technical principles, theories and/or concepts, and contributes to the development of new principles and concepts. Has a comprehensive understanding of current approaches in industry and ability to incorporate them into Exelixis' programs.
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions. Has extensive experience leading multiple projects involving complex issues and decision-making.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• Interprets, executes, and recommends modifications to companywide policies and/or divisional programs.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Demonstrated knowledge of US and international regulatory requirements.
• Dedicated to empowering the team in problem solving, strategic thinking skills with ability to impact and influence

Working Conditions:

• Environment: primarily working indoors, performing documentation work

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.