Senior Director Global Regulatory Lead - Oncology
Eli Lilly and Company
June 25, 2026
Remote friendly (Indiana, United States)
United States
Corporate Functions
Purpose
- Develop and implement innovative global regulatory strategies for products in an assigned therapeutic area; accountable decision maker for global regulatory strategy execution from portfolio entry to end-of-life.
- Lead Global Regulatory Team and create/maintain Regulatory Strategy Documents (RSD); align local plans with global brand development priorities (value proposition, workflow, labeling, risk/issues management); represent GRA on global program teams and governance.
Primary Responsibilities
- Develop/Update/Execute Global Regulatory Strategy (initiate/update RSDs; integrate team/scientific input, regulatory precedents/trends/emerging science; identify/communicate risks; drive acceleration).
- Lead Global Regulatory Team; ensure two-way communication; coach/facilitate feedback culture.
- Represent regulatory strategy on GBD/global program team; support trial design, strategic planning, and registration strategies.
- Preclinical/Early clinical: lead US submissions and amendments for IND/IDE; determine/communicate submission/approval requirements; generate regulatory documents; anticipate/resolve technical/operational issues; propose compliant innovative solutions; own US FDA relationship/interaction and execute communications to regulators and stakeholders.
- Engage external environment/portfolio assets initiatives; foster strategic relationships.
- Promotional claims/press release review direction with Global Marketing/GBD; advise on promotional strategy; partner to review/approve press and IR materials.
Lead/Influence/Partner
- Model Team Lilly behaviors; participate in cross-GRA regulatory forums; challenge for best solutions; mentor; may have direct reports.
Minimum Qualification Requirements
- Advanced scientific degree (PhD/PharmD) + 8+ years industry regulatory affairs/drug development experience; or Bachelor’s degree + 10+ years.
Preferred/Additional Qualifications
- Leadership assignments with bold leadership, communications, conflict management; 10–15% travel; US/EU/China/Japan submission/interaction experience; prior multi-country regulatory/leadership roles; direct clinical and CMC regulatory sciences; therapeutic area experience; knowledge of global regulatory procedures and reform initiatives; integrated drug development process/regulatory-business strategy depth; risk management; strong written/spoken/presentation skills; negotiation/influence; attention to detail.
Compensation & Benefits
- Anticipated wage: $169,500–$248,600; may be eligible for company bonus and comprehensive benefits (401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- Develop and implement innovative global regulatory strategies for products in an assigned therapeutic area; accountable decision maker for global regulatory strategy execution from portfolio entry to end-of-life.
- Lead Global Regulatory Team and create/maintain Regulatory Strategy Documents (RSD); align local plans with global brand development priorities (value proposition, workflow, labeling, risk/issues management); represent GRA on global program teams and governance.
Primary Responsibilities
- Develop/Update/Execute Global Regulatory Strategy (initiate/update RSDs; integrate team/scientific input, regulatory precedents/trends/emerging science; identify/communicate risks; drive acceleration).
- Lead Global Regulatory Team; ensure two-way communication; coach/facilitate feedback culture.
- Represent regulatory strategy on GBD/global program team; support trial design, strategic planning, and registration strategies.
- Preclinical/Early clinical: lead US submissions and amendments for IND/IDE; determine/communicate submission/approval requirements; generate regulatory documents; anticipate/resolve technical/operational issues; propose compliant innovative solutions; own US FDA relationship/interaction and execute communications to regulators and stakeholders.
- Engage external environment/portfolio assets initiatives; foster strategic relationships.
- Promotional claims/press release review direction with Global Marketing/GBD; advise on promotional strategy; partner to review/approve press and IR materials.
Lead/Influence/Partner
- Model Team Lilly behaviors; participate in cross-GRA regulatory forums; challenge for best solutions; mentor; may have direct reports.
Minimum Qualification Requirements
- Advanced scientific degree (PhD/PharmD) + 8+ years industry regulatory affairs/drug development experience; or Bachelor’s degree + 10+ years.
Preferred/Additional Qualifications
- Leadership assignments with bold leadership, communications, conflict management; 10–15% travel; US/EU/China/Japan submission/interaction experience; prior multi-country regulatory/leadership roles; direct clinical and CMC regulatory sciences; therapeutic area experience; knowledge of global regulatory procedures and reform initiatives; integrated drug development process/regulatory-business strategy depth; risk management; strong written/spoken/presentation skills; negotiation/influence; attention to detail.
Compensation & Benefits
- Anticipated wage: $169,500–$248,600; may be eligible for company bonus and comprehensive benefits (401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.