Senior Director Global Regulatory Lead - Oncology
Eli Lilly and Company
June 25, 2026
Remote friendly (San Francisco, CA)
United States
Corporate Functions
Purpose
- Develop and implement innovative global regulatory strategies for assigned therapeutic area product(s). Accountable decision maker for global regulatory strategy from portfolio entry to end of life cycle to meet global business objectives and affiliate requirements.
Primary Responsibilities
- Develop/Update/Execute Global Regulatory Strategy; initiate/maintain Regulatory Strategy Document (RSD) and ensure integration from Candidate Selection through end of product lifecycle (incl. NILEX).
- Lead Global Regulatory Team (GRA central, CMC, Devices, regional regulatory scientists) and maintain effective team performance and two-way communication with GBD/global program teams.
- Ensure local strategies align to global strategy and BU/brand goals (value proposition, workflow, labeling, risk/issue management).
- Provide regulatory input to development plans, remove regulatory barriers, and manage risks/issues; attend key regulatory meetings as needed.
- For preclinical/early clinical programs: lead US submission/agency interactions; own US FDA IND/IDE strategy, requirements, and FDA communications.
- Engage external environment initiatives for portfolio assets; build strategic relationships.
- Set direction for development/review/approval of promotional claims; partner with Regulatory Product Communications for press/IR materials.
- Mentor GRA personnel; may have direct reports.
Minimum Qualification Requirements
- PhD/PharmD + 8+ years regulatory affairs/drug development experience
OR Bachelor’s + 10+ years.
Other Preferences
- Leadership, conflict management, strong written/spoken/presentation skills, negotiation/influence, risk assessment/management; 10–15% travel; US/EU/China/Japan regulatory submission/interaction experience; clinical and CMC regulatory sciences; integrated drug development/process knowledge.
Benefits/Compensation (if eligible)
- Anticipated wage: $169,500–$248,600; potential company bonus; comprehensive benefits (401(k), pension, medical/dental/vision, PTO, life insurance, flexible benefits, well-being).
- Develop and implement innovative global regulatory strategies for assigned therapeutic area product(s). Accountable decision maker for global regulatory strategy from portfolio entry to end of life cycle to meet global business objectives and affiliate requirements.
Primary Responsibilities
- Develop/Update/Execute Global Regulatory Strategy; initiate/maintain Regulatory Strategy Document (RSD) and ensure integration from Candidate Selection through end of product lifecycle (incl. NILEX).
- Lead Global Regulatory Team (GRA central, CMC, Devices, regional regulatory scientists) and maintain effective team performance and two-way communication with GBD/global program teams.
- Ensure local strategies align to global strategy and BU/brand goals (value proposition, workflow, labeling, risk/issue management).
- Provide regulatory input to development plans, remove regulatory barriers, and manage risks/issues; attend key regulatory meetings as needed.
- For preclinical/early clinical programs: lead US submission/agency interactions; own US FDA IND/IDE strategy, requirements, and FDA communications.
- Engage external environment initiatives for portfolio assets; build strategic relationships.
- Set direction for development/review/approval of promotional claims; partner with Regulatory Product Communications for press/IR materials.
- Mentor GRA personnel; may have direct reports.
Minimum Qualification Requirements
- PhD/PharmD + 8+ years regulatory affairs/drug development experience
OR Bachelor’s + 10+ years.
Other Preferences
- Leadership, conflict management, strong written/spoken/presentation skills, negotiation/influence, risk assessment/management; 10–15% travel; US/EU/China/Japan regulatory submission/interaction experience; clinical and CMC regulatory sciences; integrated drug development/process knowledge.
Benefits/Compensation (if eligible)
- Anticipated wage: $169,500–$248,600; potential company bonus; comprehensive benefits (401(k), pension, medical/dental/vision, PTO, life insurance, flexible benefits, well-being).