Senior Director Global Regulatory Lead - Oncology
Eli Lilly and Company
June 25, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Purpose
- Develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area, accountable from portfolio entry through end of lifecycle.
Primary Responsibilities
- Develop/Update/Execute Global Regulatory Strategy (initiate and maintain Regulatory Strategy Document, RSD); integrate into development plans from candidate selection to end of product lifecycle (incl. NILEX); identify and communicate regulatory risks.
- Lead Global Regulatory Team (GRA central, GRA-CMC, GRA-Devices, regional regulatory scientists); create maintain RSD(s); ensure alignment of local plans with Global Brand Development/global program priorities (value proposition, workflow, labeling, risk/issues management).
- Represent GRA on GBD/global program team; attend key governance/agency meetings as needed; drive solutions to regulatory/development barriers.
- Preclinical/early clinical: lead US IND/IDE submission and amendments; determine/communicate requirements and regulator expectations; generate regulatory documents; anticipate/resolve issues; own US FDA interaction/communications.
- Lead/influence external portfolio-related initiatives and relationships.
- Press/promotional claim review direction in partnership with Marketing/GBD and Regulatory Product Communications.
- Lead/partner behaviors; may have direct reports; mentor GRA personnel.
Minimum Qualifications
- PhD/PharmD with 8+ years regulatory affairs and/or drug development experience; or Bachelor’s with 10+ years.
Preferred/Additional
- Leadership and conflict management; travel 10–15%; US/EU/China/Japan submission/interactions; cross-country regulatory leadership; clinical and CMC regulatory experience; therapeutic area experience; global regulatory knowledge; strong communication; negotiation/influence; risk management; attention to detail.
Compensation/Benefits (as stated)
- Anticipated base pay: $169,500–$248,600; possible company bonus; comprehensive benefits (e.g., 401(k), insurance, vacation, flexible benefits, well-being).
- Develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area, accountable from portfolio entry through end of lifecycle.
Primary Responsibilities
- Develop/Update/Execute Global Regulatory Strategy (initiate and maintain Regulatory Strategy Document, RSD); integrate into development plans from candidate selection to end of product lifecycle (incl. NILEX); identify and communicate regulatory risks.
- Lead Global Regulatory Team (GRA central, GRA-CMC, GRA-Devices, regional regulatory scientists); create maintain RSD(s); ensure alignment of local plans with Global Brand Development/global program priorities (value proposition, workflow, labeling, risk/issues management).
- Represent GRA on GBD/global program team; attend key governance/agency meetings as needed; drive solutions to regulatory/development barriers.
- Preclinical/early clinical: lead US IND/IDE submission and amendments; determine/communicate requirements and regulator expectations; generate regulatory documents; anticipate/resolve issues; own US FDA interaction/communications.
- Lead/influence external portfolio-related initiatives and relationships.
- Press/promotional claim review direction in partnership with Marketing/GBD and Regulatory Product Communications.
- Lead/partner behaviors; may have direct reports; mentor GRA personnel.
Minimum Qualifications
- PhD/PharmD with 8+ years regulatory affairs and/or drug development experience; or Bachelor’s with 10+ years.
Preferred/Additional
- Leadership and conflict management; travel 10–15%; US/EU/China/Japan submission/interactions; cross-country regulatory leadership; clinical and CMC regulatory experience; therapeutic area experience; global regulatory knowledge; strong communication; negotiation/influence; risk management; attention to detail.
Compensation/Benefits (as stated)
- Anticipated base pay: $169,500–$248,600; possible company bonus; comprehensive benefits (e.g., 401(k), insurance, vacation, flexible benefits, well-being).