Director, Regulatory Affairs

Job Description

The Director, Regulatory Affairs demonstrates proficiency in understanding and interpreting clinical trial data to support Regulatory and cross-functional activities for Exelixis compounds. This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role also exercises strategic approaches concerning product labeling and is a central point of contact for driving product labeling initiatives. This role also have responsibility and oversight of trial data disclosure per regulatory requirements and other regulatory compliance related initiatives. This role demonstrates cross-functional leadership, recognizing opportunities for multi-disciplinary collaboration and challenges regarding communication strategies and initiatives that cross multiple channels.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsibility for the regulatory review and approval of scientific exchange materials, including Medical Information requests, materials for the Medical Affairs field staff, and clinical trial support materials (e.g., external patient recruitment materials). Decision-making member of the Medical and Scientific Exchange Review Committee. Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters. Liaises cross-functionally with partners in Medical Affairs, Regulatory, Legal, Public Relations, and others to develop holistic strategies around communication initiatives, working within the regulatory framework and boundaries. Provides strategic and forward-looking guidance regarding processes and systems surrounding review committees. Demonstrates a thorough knowledge of end-to-end labeling processes. Manages the labeling governance process, working with cross-functional stakeholders to meet strategic business goals. Partners within Regulatory to align across filing and labeling strategies. Provides strategic and operational direction on product labeling. Responsible for the development and drafting of new product labeling, labeling for additional indications, and other labeling changes (e.g., new safety information) for Exelixis products. Responsibility and oversight of compliance with clinical trial disclosure requirements (e.g., clinicaltrials.gov, EudraCT), through direct reports and as an individual contributor as needed. Potential responsibility and oversight (through direct reports and as an individual contributor as needed) of other compliance-related initiatives within Regulatory and cross-functionally as the Regulatory partner (e.g., audit and inspection preparation, clinical trial results disclosure, business continuity and departmental processes). Contributes 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 and company growth. Provides leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations. Liaises internally with members of Exelixis’ functional departments. Liaises externally with vendors, partners, and joint development collaborators.

SUPERVISORY RESPONSIBILITIES: Directly supervise employee(s). Indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education: Bachelor’s degree in related discipline and a minimum of twelve years of related experience; or Master’s degree in related discipline and a minimum of ten 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.

Experience/The Ideal Candidate will have: Minimum ten years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training Minimum eight years regulatory experience in a position of substantial responsibility. Prior experience working with OPDP and/or review divisions at FDA required. Experience in oncology preferred.

Knowledge/Skills: Demonstrated knowledge of US and international regulatory requirements pertinent to this role. 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. Exercises problem solving, strategic thinking skills with ability to impact and influence Guides the successful completion of major programs, projects and/or functions. Interprets, executes, and recommends modifications to departmental and cross-functional processes and standards. Leads or manage 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. Trains staff. Performs a variety of complicated tasks with a wide degree of creativity and latitude. Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues Has good general knowledge of other related disciplines. Applies strong analytical and business communication skills.

WORKING CONDITIONS: Environment: primarily working indoors, performing administrative work#LI-MB1

Additional Information

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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.