Senior Director Global Regulatory Lead - Oncology
Eli Lilly and Company
June 25, 2026
Remote friendly (Stamford, CT)
United States
Corporate Functions
Purpose
- Develop and implement innovative global regulatory strategies for assigned therapeutic area product(s) from portfolio entry to end of life; accountable decision maker for execution and alignment to global/regional needs.
Primary Responsibilities
- Develop/update/execute Global Regulatory Strategy Document(s) (RSD) and integrate into development plans (from candidate selection through end of product lifecycle, incl. NILEX).
- Lead Global Regulatory Team; maintain regulatory team effectiveness, enable two-way communication, coach feedback culture.
- Ensure local strategies deliver against global regulatory strategy and BU/brand goals; provide timely updates to GBD/BU stakeholders.
- Represent GRA on GBD/global program team; support trial design, registration strategies across in-scope countries; drive solutions to regulatory barriers and manage risks.
- For preclinical/early clinical: lead US submissions and interactions; develop IND/IDE submission/amendment strategy, define requirements, generate regulator-ready documents, resolve technical/strategic issues, and own US FDA interaction strategy.
- Lead/partner as needed on external environment initiatives; set direction for promotional claims/press materials with Global Marketing/GBD and regulatory product communications.
Minimum Qualifications
- PhD/PharmD and 8+ years industry regulatory affairs/drug development experience, OR Bachelor’s degree and 10+ years.
Preferred/Additional
- Leadership experience; US/EU/China/Japan regulatory submission & interaction experience; clinical + CMC regulatory sciences; global regulatory procedures; strong communication, negotiation/influence, risk management; travel 10–15%.
Compensation/Benefits (as stated)
- Anticipated wage: $169,500–$248,600; bonus eligibility; comprehensive benefits incl. 401(k), medical/dental/vision, life insurance, vacation, and well-being benefits.
- Develop and implement innovative global regulatory strategies for assigned therapeutic area product(s) from portfolio entry to end of life; accountable decision maker for execution and alignment to global/regional needs.
Primary Responsibilities
- Develop/update/execute Global Regulatory Strategy Document(s) (RSD) and integrate into development plans (from candidate selection through end of product lifecycle, incl. NILEX).
- Lead Global Regulatory Team; maintain regulatory team effectiveness, enable two-way communication, coach feedback culture.
- Ensure local strategies deliver against global regulatory strategy and BU/brand goals; provide timely updates to GBD/BU stakeholders.
- Represent GRA on GBD/global program team; support trial design, registration strategies across in-scope countries; drive solutions to regulatory barriers and manage risks.
- For preclinical/early clinical: lead US submissions and interactions; develop IND/IDE submission/amendment strategy, define requirements, generate regulator-ready documents, resolve technical/strategic issues, and own US FDA interaction strategy.
- Lead/partner as needed on external environment initiatives; set direction for promotional claims/press materials with Global Marketing/GBD and regulatory product communications.
Minimum Qualifications
- PhD/PharmD and 8+ years industry regulatory affairs/drug development experience, OR Bachelor’s degree and 10+ years.
Preferred/Additional
- Leadership experience; US/EU/China/Japan regulatory submission & interaction experience; clinical + CMC regulatory sciences; global regulatory procedures; strong communication, negotiation/influence, risk management; travel 10–15%.
Compensation/Benefits (as stated)
- Anticipated wage: $169,500–$248,600; bonus eligibility; comprehensive benefits incl. 401(k), medical/dental/vision, life insurance, vacation, and well-being benefits.