Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Interacts directly with regulatory agencies.
Conducts effective and timely regulatory intelligence and research. Provides risk assessments and recommendations for various regulatory scenarios.
Represents Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late stage development programs.
Works with external vendors to plan, prepare, submit, and maintain CTAs in Europe, Asia, and other regions
Reviews nonclinical, chemistry, manufacturing and controls, and clinical trial-related documentation (eg, protocols, informed consents, clinical study reports) for compliance with regulatory guidances and alignment with study objectives and regulatory strategy
Coordinates and evaluates documents submitted to regulatory health authorities to assure that they are complete, organized, of high quality, and compliant with applicable regional regulations.
Oversees the preparation and completion of regulatory submissions (electronic and paper), including new drug applications, supplements and amendments, investigational new drug applications, IND safety reports, annual reports, and other routine amendments.
Contributes in the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs
Liaises internally with members of Exelixis' functional departments.
Liaises externally with vendors, licensors and joint development collaborators
SUPERVISORY RESPONSIBILITIES:
Directly supervise team.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
BS/BA degree in related discipline and a minimum of eleven years of related experience; or
MS/MA degree in related discipline and a minimum of nine years of related experience; or
PhD in related discipline and a minimum of five 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 of seven years of direct experience developing regulatory strategies
Relevant working experience with US and/or ex-US health authorities.
Experience in oncology drug development.
Knowledge/Skills:
Working knowledge of US and/or 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.
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.
May contribute 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.
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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.
