Associate Regulatory Affairs Strategy Director (Oncology)
Exelixis
June 24, 2026
Remote friendly (Alameda, CA)
United States
Corporate Functions
SUMMARY/JOB PURPOSE
Responsible for the development and implementation of global regulatory strategies aligned with asset and corporate goals and health authority requirements. Ensures timely preparation of organized, consistent, scientifically valid submissions. Translates regulatory requirements into practical plans and communicates clearly with stakeholders to reduce regulatory risk.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence/research; provide guidance, risk assessments, and recommendations (including expedited pathways).
- Represent Regulatory Affairs on multidisciplinary teams to establish development and regulatory strategies for early/late-stage programs.
- Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment with study objectives and strategy.
- Coordinate, author, and evaluate regulatory documents to ensure completeness, organization, quality, appropriate messaging, and compliance with regional regulations.
- Oversee regulatory submissions (electronic/paper), including INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, and NDAs/BLAs.
- Contribute to process improvements (work instructions and company SOPs).
- Lead multiple assets/studies as assigned.
- Liaise internally with functional departments; externally with vendors, licensors, consultants, and joint development collaborators.
QUALIFICATIONS
- Bachelor’s degree + 11+ years; or Master’s + 9+ years; or PhD + 5+ years; or equivalent combination.
SKILLS/EXPERIENCE
- Ability to manage timelines and multiple activities; deliver high-quality work.
- Broad regulatory framework knowledge; develop innovative approaches for complex work.
- Strong verbal/written communication; effective stakeholder presentations.
- Strong interpersonal skills; collaborate to resolve differing views.
- Ability to manage teams and build productive relationships.
- Problem-solving through data gathering/analysis/application.
WORKING CONDITIONS
- Travel ~10%.
Responsible for the development and implementation of global regulatory strategies aligned with asset and corporate goals and health authority requirements. Ensures timely preparation of organized, consistent, scientifically valid submissions. Translates regulatory requirements into practical plans and communicates clearly with stakeholders to reduce regulatory risk.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence/research; provide guidance, risk assessments, and recommendations (including expedited pathways).
- Represent Regulatory Affairs on multidisciplinary teams to establish development and regulatory strategies for early/late-stage programs.
- Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment with study objectives and strategy.
- Coordinate, author, and evaluate regulatory documents to ensure completeness, organization, quality, appropriate messaging, and compliance with regional regulations.
- Oversee regulatory submissions (electronic/paper), including INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, and NDAs/BLAs.
- Contribute to process improvements (work instructions and company SOPs).
- Lead multiple assets/studies as assigned.
- Liaise internally with functional departments; externally with vendors, licensors, consultants, and joint development collaborators.
QUALIFICATIONS
- Bachelor’s degree + 11+ years; or Master’s + 9+ years; or PhD + 5+ years; or equivalent combination.
SKILLS/EXPERIENCE
- Ability to manage timelines and multiple activities; deliver high-quality work.
- Broad regulatory framework knowledge; develop innovative approaches for complex work.
- Strong verbal/written communication; effective stakeholder presentations.
- Strong interpersonal skills; collaborate to resolve differing views.
- Ability to manage teams and build productive relationships.
- Problem-solving through data gathering/analysis/application.
WORKING CONDITIONS
- Travel ~10%.