Senior Director, Regulatory Affairs (Oncology)

Summary / Job Purpose Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly and proactively with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies. Essential Duties and Responsibilities Interact directly with regulatory authorities, conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams, provide risk assessments and recommendations for various regulatory scenarios including expedited pathways, represent Regulatory Affairs in multidisciplinary teams to establish development and regulatory strategies for early and late‑stage programs, work with external vendors to plan, review, prepare, submit and maintain CTAs in Europe, Asia and other regions, review clinical trial‑related documentation for compliance with regulatory guidance and alignment with study objectives and regulatory strategy, lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, high quality, contain appropriate messaging and are compliant with applicable regional regulations, oversee the preparation and completion of regulatory submissions (e.g. investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments and new drug applications or biologics license applications), contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs, and lead multiple assets and/or studies as assigned. Supervisory Responsibilities Directly supervise employees. Education, Experience, Knowledge & Skills Education / Experience: Bachelor’s degree in a related discipline and a minimum of fifteen years of related experience. Master’s degree in a related discipline and a minimum of thirteen years of related experience. PhD degree in a related discipline and a minimum of twelve years of related experience. Equivalent combination of education and experience. Key Skills and Competencies Develops and manages plans, establishes timelines and sets standards for performance. Effectively communicates priorities and motivates team to achieve business objectives. Resourceful and persistent in overcoming obstacles and managing ambiguity. Applies extensive regulatory knowledge to develop innovative approaches and manage team work. Anticipates potential changes, challenges status quo to drive continuous improvement. Strong interpersonal skills, ability to accommodate differing views and influence resolution. Identifies potential conflicts and takes preventive action. Builds cohesive teams and facilitates team alignment and achievement of common goals. Engages internal and external stakeholders to establish productive collaborative relationships. Leads and manages the team with integrity, builds trust and executes department goals. Serves as a role model, encouraging ethical behavior and accountability. Job Complexity Capable of proactively assessing workload, trends, tasks and priorities for cross‑functional activity; plans and executes multiple projects or activities, considering alternative methods and contingency plans; designs and implements solutions to address cross‑functional project level challenges; engages, influences and collaborates with stakeholders on cross‑functional projects. Working Conditions Travel approximately 20%. Office is a modern space fostering collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. All necessary equipment, including dual monitors and ergonomic chairs, is provided to ensure a comfortable workspace. Equal Opportunity Employer 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. #J-18808-Ljbffr Exelixis Inc