SUMMARY/JOB PURPOSE:

Manages 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. Provides expertise in translating regulatory requirements into practical, workable plans.

Essential Duties And Responsibilities:

• Lead and oversee development plans incorporating regulatory strategies designed to maximize chances of successful and expedient registration.

• Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early through late-stage development programs. Manage clinical development program planning to anticipate changes in regulatory environment and approval requirements.

• Conduct effective and timely regulatory intelligence and research. Monitor current and proposed regulatory issues. Provide risk assessments and recommendations for various regulatory scenarios.

• Work with external vendors to plan, prepare, submit, and maintain CTAs in Europe, Asia, and other regions

• Critically review nonclinical, chemistry, manufacturing and controls, and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidances. Provides regulatory strategic guidance on documents and submission plans to align with study and company objectives.

• Interact directly with regulatory agencies; manages agency interactions.

• Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations.

• Support review of medical communications across the development portfolio for use by the Clinical Study Teams and the Medical Affairs organization, applying regulatory principles for appropriate content and use.

• 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.

Supervisory Responsibilities:

• Directly supervise employees.

• Indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

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

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

• PhD in related discipline and a minimum of eight 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 fourteen years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training

• Minimum seven years of 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:

• Demonstrated knowledge of US and international regulatory requirements.

• 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.

• Contributes to training of 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.

JOB COMPLEXITY:

• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.

• Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.

• Creates formal networks involving coordination among groups.

Working Conditions:

Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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.