Senior Director, Regulatory Affairs (Oncology)
Exelixis
June 24, 2026
Remote friendly (Alameda, CA)
United States
Corporate Functions
SUMMARY/JOB PURPOSE
Responsible for driving the development and implementation of global regulatory strategies aligned with asset/corporate goals and health authority requirements. Ensures timely preparation of organized, consistent, scientifically valid submissions. Translates regulatory requirements into practical, workable plans and proactively communicates with stakeholders to reduce regulatory risk.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence/research; provide risk assessments and recommendations for study/asset teams, including possible expedited pathways.
- Represent Regulatory Affairs on 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 (Europe, Asia, and other regions).
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment with objectives/strategy.
- Lead/author/evaluate regulatory authority submissions to ensure completeness, organization, quality, appropriate messaging, and regional compliance.
- Oversee preparation and completion of regulatory submissions (e.g., INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, NDAs/BLAs).
- Contribute to processes/procedures, including authoring internal work instructions and company SOPs.
- Lead multiple assets/studies as assigned.
SUPERVISORY RESPONSIBILITIES
- Directly supervise employees.
EDUCATION/EXPERIENCE
- Bachelor’s + 15 years; or Master’s + 13 years; or PhD + 12 years; or equivalent education/experience.
SKILLS/QUALIFICATIONS
- Strong planning/timeline management, prioritization, and performance standards; manages ambiguity and delivers high-quality work.
- Deep knowledge of regulatory requirements and industry practices; develops innovative approaches and drives continuous improvement.
- Strong interpersonal skills; builds teams and aligns stakeholders.
- Advanced problem-solving and regulatory expertise for cross-functional teams.
- Demonstrated leadership with integrity.
JOB COMPLEXITY
- Proactively assess workload/priorities; plan multiple projects with contingencies; design solutions for cross-functional challenges.
WORKING CONDITIONS
- Travel ~20%.
Responsible for driving the development and implementation of global regulatory strategies aligned with asset/corporate goals and health authority requirements. Ensures timely preparation of organized, consistent, scientifically valid submissions. Translates regulatory requirements into practical, workable plans and proactively communicates with stakeholders to reduce regulatory risk.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence/research; provide risk assessments and recommendations for study/asset teams, including possible expedited pathways.
- Represent Regulatory Affairs on 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 (Europe, Asia, and other regions).
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment with objectives/strategy.
- Lead/author/evaluate regulatory authority submissions to ensure completeness, organization, quality, appropriate messaging, and regional compliance.
- Oversee preparation and completion of regulatory submissions (e.g., INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, NDAs/BLAs).
- Contribute to processes/procedures, including authoring internal work instructions and company SOPs.
- Lead multiple assets/studies as assigned.
SUPERVISORY RESPONSIBILITIES
- Directly supervise employees.
EDUCATION/EXPERIENCE
- Bachelor’s + 15 years; or Master’s + 13 years; or PhD + 12 years; or equivalent education/experience.
SKILLS/QUALIFICATIONS
- Strong planning/timeline management, prioritization, and performance standards; manages ambiguity and delivers high-quality work.
- Deep knowledge of regulatory requirements and industry practices; develops innovative approaches and drives continuous improvement.
- Strong interpersonal skills; builds teams and aligns stakeholders.
- Advanced problem-solving and regulatory expertise for cross-functional teams.
- Demonstrated leadership with integrity.
JOB COMPLEXITY
- Proactively assess workload/priorities; plan multiple projects with contingencies; design solutions for cross-functional challenges.
WORKING CONDITIONS
- Travel ~20%.