Assoc Regulatory Affairs Strategy Director (Oncology)
Exelixis
August 20, 2026
On-site
Alameda, CA
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 and translates regulatory requirements into practical, workable plans. Communicates with stakeholders to reduce regulatory risk and drive mitigation strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence and research; provide guidance, risk assessments, and recommendations for regulatory scenarios (including expedited pathways).
- Represent Regulatory Affairs in multi-disciplinary 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 documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment.
- Coordinate, author, and evaluate submissions to ensure completeness, organization, quality, appropriate messaging, and regional regulatory compliance.
- Oversee regulatory submissions (electronic and paper): INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, and NDA/BLA.
- Contribute to processes/procedures, including internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
- Liaise internally with functional departments; externally with vendors, licensors, consultants, and collaborators.
QUALIFICATIONS (EDUCATION/EXPERIENCE):
- Bachelor’s + 11 years; or Master’s + 9 years; or PhD + 5 years; or equivalent.
SKILLS / EXPERIENCE:
- Manage multiple activities within timelines; deliver high-quality work.
- Apply regulatory framework knowledge to develop innovative solutions.
- Clear verbal/written communication; strong interpersonal skills and stakeholder collaboration.
- Lead teams effectively; integrity and trust-building.
JOB COMPLEXITY:
- Prioritize and manage multiple tasks; proactively resolve challenges and implement solutions.
WORKING CONDITIONS:
- Travel ~10%.
BENEFITS (if applicable):
- 401k with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); company stock; long-term incentives; 15 vacation days; 17 paid holidays (incl. winter shutdown); up to 10 sick days.
APPLICATION INSTRUCTIONS:
- If you need a disability accommodation for the recruiting process, email ApplicantAccommodations@exelixis.com.
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 and translates regulatory requirements into practical, workable plans. Communicates with stakeholders to reduce regulatory risk and drive mitigation strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence and research; provide guidance, risk assessments, and recommendations for regulatory scenarios (including expedited pathways).
- Represent Regulatory Affairs in multi-disciplinary 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 documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment.
- Coordinate, author, and evaluate submissions to ensure completeness, organization, quality, appropriate messaging, and regional regulatory compliance.
- Oversee regulatory submissions (electronic and paper): INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, and NDA/BLA.
- Contribute to processes/procedures, including internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
- Liaise internally with functional departments; externally with vendors, licensors, consultants, and collaborators.
QUALIFICATIONS (EDUCATION/EXPERIENCE):
- Bachelor’s + 11 years; or Master’s + 9 years; or PhD + 5 years; or equivalent.
SKILLS / EXPERIENCE:
- Manage multiple activities within timelines; deliver high-quality work.
- Apply regulatory framework knowledge to develop innovative solutions.
- Clear verbal/written communication; strong interpersonal skills and stakeholder collaboration.
- Lead teams effectively; integrity and trust-building.
JOB COMPLEXITY:
- Prioritize and manage multiple tasks; proactively resolve challenges and implement solutions.
WORKING CONDITIONS:
- Travel ~10%.
BENEFITS (if applicable):
- 401k with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); company stock; long-term incentives; 15 vacation days; 17 paid holidays (incl. winter shutdown); up to 10 sick days.
APPLICATION INSTRUCTIONS:
- If you need a disability accommodation for the recruiting process, email ApplicantAccommodations@exelixis.com.