Executive Director, Regulatory Strategy
Exelixis
August 19, 2026
On-site
Alameda, CA
Corporate Functions
Summary/Job Purpose:
Executive Director, Regulatory Affairs oversees all regulatory activities for new development programs (pre-IND through BLA/NDA and post-approval). Develops and implements global regulatory strategies across clinical, non-clinical, and CMC, translating regulatory requirements into practical plans and leading earliest possible approvals from Phase 1–4. Manages the clinical regulatory team and ensures timely, high-quality, scientifically valid submissions while interacting with regulatory agencies.
Essential Duties & Responsibilities:
- Oversee and manage Regulatory Program Leaders and staff.
- Develop regulatory strategy plans to maximize successful registration.
- Maintain strong relationships with FDA; monitor regulatory climate and relevant policies/key personnel.
- Ensure regulatory submissions are complete, well organized, high-quality, compliant, and review-facilitating.
- Manage requirements for additional indications and new dosage forms.
- Plan clinical development to anticipate regulatory environment/approval requirement changes.
- Lead interactions with health authorities to enable timely reviews and approvals.
- Ensure preparation/submission of INDs, NDAs, BLAs, reports, and correspondence per best practices.
- Plan and manage regulatory meetings; coordinate adverse reaction and follow-up safety reports within timelines.
- Review nonclinical/CMC/clinical documentation (protocols, consents, CSRs) for compliance.
- Provide regulatory strategic guidance; lead process/SOP and work-instruction optimization.
- Liaise internally with functional teams and externally with vendors/licensors/collaborators; develop staff and individual development plans.
Supervisory Responsibilities:
- Provide direction; supervise hiring/scheduling/assignments and performance; manage through subordinate supervisors.
Qualifications:
- BS/BA + 18 years; MS/MA + 16 years; PhD + 15 years (or equivalent).
- Minimum 18 years pharma/regulatory experience; minimum 9 years regulatory experience in roles of substantial responsibility.
- Prior FDA review-division experience.
- Oncology drug development experience required.
- May require certification.
Skills/Knowledge:
- Demonstrated expertise in US and international regulatory requirements; strong analytical and communication skills.
- Ability to lead multiple complex programs/projects and influence strategic outcomes.
Benefits (Total Rewards):
- 401(k) with company contributions; medical/dental/vision; life & disability; flexible spending accounts; discretionary annual bonus (or sales incentive plan for field sales); stock purchase; long-term incentives; 15 vacation days (first year); 17 paid holidays including winter shutdown in December; up to 10 sick days.
Executive Director, Regulatory Affairs oversees all regulatory activities for new development programs (pre-IND through BLA/NDA and post-approval). Develops and implements global regulatory strategies across clinical, non-clinical, and CMC, translating regulatory requirements into practical plans and leading earliest possible approvals from Phase 1–4. Manages the clinical regulatory team and ensures timely, high-quality, scientifically valid submissions while interacting with regulatory agencies.
Essential Duties & Responsibilities:
- Oversee and manage Regulatory Program Leaders and staff.
- Develop regulatory strategy plans to maximize successful registration.
- Maintain strong relationships with FDA; monitor regulatory climate and relevant policies/key personnel.
- Ensure regulatory submissions are complete, well organized, high-quality, compliant, and review-facilitating.
- Manage requirements for additional indications and new dosage forms.
- Plan clinical development to anticipate regulatory environment/approval requirement changes.
- Lead interactions with health authorities to enable timely reviews and approvals.
- Ensure preparation/submission of INDs, NDAs, BLAs, reports, and correspondence per best practices.
- Plan and manage regulatory meetings; coordinate adverse reaction and follow-up safety reports within timelines.
- Review nonclinical/CMC/clinical documentation (protocols, consents, CSRs) for compliance.
- Provide regulatory strategic guidance; lead process/SOP and work-instruction optimization.
- Liaise internally with functional teams and externally with vendors/licensors/collaborators; develop staff and individual development plans.
Supervisory Responsibilities:
- Provide direction; supervise hiring/scheduling/assignments and performance; manage through subordinate supervisors.
Qualifications:
- BS/BA + 18 years; MS/MA + 16 years; PhD + 15 years (or equivalent).
- Minimum 18 years pharma/regulatory experience; minimum 9 years regulatory experience in roles of substantial responsibility.
- Prior FDA review-division experience.
- Oncology drug development experience required.
- May require certification.
Skills/Knowledge:
- Demonstrated expertise in US and international regulatory requirements; strong analytical and communication skills.
- Ability to lead multiple complex programs/projects and influence strategic outcomes.
Benefits (Total Rewards):
- 401(k) with company contributions; medical/dental/vision; life & disability; flexible spending accounts; discretionary annual bonus (or sales incentive plan for field sales); stock purchase; long-term incentives; 15 vacation days (first year); 17 paid holidays including winter shutdown in December; up to 10 sick days.