Senior Director, Regulatory Affairs (Oncology)
Exelixis
August 06, 2026
Remote friendly (Alameda, CA)
United States
Corporate Functions
SUMMARY / JOB PURPOSE
- Drive development and implementation of global regulatory strategies aligned with asset/corporate goals and health authority requirements.
- Ensure timely, organized, consistent, scientifically valid regulatory submissions.
- Translate regulatory requirements into practical plans and proactively communicate with stakeholders to reduce regulatory risk.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence/research to guide study and asset teams; provide risk assessments and recommendations (including possible expedited pathways).
- Represent Regulatory Affairs on multidisciplinary teams to set development and regulatory strategies for early and late-stage programs.
- Plan, review, prepare, submit, and maintain CTAs with external vendors across Europe, Asia, and other regions.
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment to objectives/strategy.
- Lead, author, and evaluate regulatory authority submissions for completeness, quality, messaging, and regional compliance.
- Oversee regulatory submissions (electronic/paper), including INDs, supplements/amendments, IND safety reports, DSURs/annual reports, routine amendments, and NDA/BLA.
- Develop and author internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
QUALIFICATIONS / EDUCATION / EXPERIENCE
- Bachelor’s (15+ years) or Master’s (13+ years) or PhD (12+ years) in a related discipline; or equivalent combination.
REQUIRED SKILLS / EXPERIENCE
- Extensive regulatory knowledge; ability to develop innovative approaches, manage plans/timelines, balance multiple activities, and lead teams.
- Strong interpersonal skills; ability to resolve differing views and prevent conflict.
- Advanced analytical/problem-solving; provides regulatory expertise to cross-functional teams.
- Ability to assess workload/priorities, plan with contingencies, and collaborate across stakeholders.
SUPERVISORY RESPONSIBILITIES
- Directly supervise employees.
WORKING CONDITIONS
- Travel approximately 20%.
- Drive development and implementation of global regulatory strategies aligned with asset/corporate goals and health authority requirements.
- Ensure timely, organized, consistent, scientifically valid regulatory submissions.
- Translate regulatory requirements into practical plans and proactively communicate with stakeholders to reduce regulatory risk.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence/research to guide study and asset teams; provide risk assessments and recommendations (including possible expedited pathways).
- Represent Regulatory Affairs on multidisciplinary teams to set development and regulatory strategies for early and late-stage programs.
- Plan, review, prepare, submit, and maintain CTAs with external vendors across Europe, Asia, and other regions.
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment to objectives/strategy.
- Lead, author, and evaluate regulatory authority submissions for completeness, quality, messaging, and regional compliance.
- Oversee regulatory submissions (electronic/paper), including INDs, supplements/amendments, IND safety reports, DSURs/annual reports, routine amendments, and NDA/BLA.
- Develop and author internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
QUALIFICATIONS / EDUCATION / EXPERIENCE
- Bachelor’s (15+ years) or Master’s (13+ years) or PhD (12+ years) in a related discipline; or equivalent combination.
REQUIRED SKILLS / EXPERIENCE
- Extensive regulatory knowledge; ability to develop innovative approaches, manage plans/timelines, balance multiple activities, and lead teams.
- Strong interpersonal skills; ability to resolve differing views and prevent conflict.
- Advanced analytical/problem-solving; provides regulatory expertise to cross-functional teams.
- Ability to assess workload/priorities, plan with contingencies, and collaborate across stakeholders.
SUPERVISORY RESPONSIBILITIES
- Directly supervise employees.
WORKING CONDITIONS
- Travel approximately 20%.