Senior Director, Regulatory Affairs; Oncology) Exelixis · Alameda –ago

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.

• 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 possible expedited pathways.
• Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
• Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
• Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) 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, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
• Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Lead multiple assets and/or studies as assigned.

• Directly supervise employees.

• Bachelor’s degree in related discipline and a minimum of fifteen years of related experience; or,
• Master’s degree in related discipline and a minimum of thirteen years of related experience; or,
• PhD degree in related discipline and a minimum of twelve years of related experience; or,
• Equivalent combination of education and experience.

• Develops and manages plans, establishes timelines, sets standards for performance. Manages and effectively communicates priorities. Motivates self and others to achieve business objectives and deliver results for areas of responsibility. Resourceful and persistent in overcoming obstacles, even when confronted with ambiguity or barriers. Takes pride in delivering high quality work.
• Applies extensive knowledge of regulatory requirements, industry drivers and practices to develop innovative approaches and manage the work of a team. Anticipates potential changes and challenges the status quo to drive continuous improvement.
• Develops and manages plans, establishes timelines, sets standards for performance and balances commitments to complete multiple activities and achieve results for areas of responsibility.
• Strong interpersonal skills and demonstrable ability to accommodate differing views to influence an agreed upon resolution. Identifies potential for conflict and takes preventive action.
• Effective builder of cohesive teams, facilitates team alignment and achievement of common goals. Independently engages internal and external stakeholders to establish productive collaborative relationships.
• Establishes objectives for areas of responsibility and plans…