Associate/Sr. Associate/Manager - Global CMC Regulatory, Regulatory Delivery and Excellence
Eli Lilly and Company
June 27, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Responsibilities:
- Lead CMC submission management, including ICH CTD and evolving global agency standards; prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.
- Partner with GRA-CMC Scientists to plan and prepare submission content for clinical studies and manufacturing process changes (development and marketed products).
- Drive execution of global registration and maintenance submission planning.
- Triage Lilly affiliate inquiries/requests and, when needed, consult with GRA-CMC Scientists to prepare responses.
- Implement/interpret global regulations and guidance using regulatory precedence to ensure document content/structure align with local requirements; partner with Regional Submission Associates on new submission standards.
- Align on submission strategies, timelines, deliverables, and manage communications among Regional Submission Associates, GRA-CMC scientists, RD&E specialists, and Quality/Regulatory representatives.
Qualifications:
- Bachelor’s degree in a scientific/health sciences field (e.g., pharmacy, chemistry, or related).
- 2+ years of pharmaceutical drug development experience.
- Authorized to work in the United States full-time (Lilly does not sponsor visas).
Skills/Preferences:
- 1+ year using Veeva RIM.
- Knowledge of agency submission procedures; awareness of emerging electronic submission standards.
- Ability to operate in a regulated environment; written/spoken/presentation skills.
- Negotiation/influence, project management experience, attention to detail, prioritization.
- Strong teamwork and adaptability across diverse interpersonal styles.
Benefits:
- 401(k) eligibility; pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; certain time off/leave; well-being benefits (EAP, fitness, clubs/activities).
Additional Info:
- Travel less than 5%.
- Lead CMC submission management, including ICH CTD and evolving global agency standards; prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.
- Partner with GRA-CMC Scientists to plan and prepare submission content for clinical studies and manufacturing process changes (development and marketed products).
- Drive execution of global registration and maintenance submission planning.
- Triage Lilly affiliate inquiries/requests and, when needed, consult with GRA-CMC Scientists to prepare responses.
- Implement/interpret global regulations and guidance using regulatory precedence to ensure document content/structure align with local requirements; partner with Regional Submission Associates on new submission standards.
- Align on submission strategies, timelines, deliverables, and manage communications among Regional Submission Associates, GRA-CMC scientists, RD&E specialists, and Quality/Regulatory representatives.
Qualifications:
- Bachelor’s degree in a scientific/health sciences field (e.g., pharmacy, chemistry, or related).
- 2+ years of pharmaceutical drug development experience.
- Authorized to work in the United States full-time (Lilly does not sponsor visas).
Skills/Preferences:
- 1+ year using Veeva RIM.
- Knowledge of agency submission procedures; awareness of emerging electronic submission standards.
- Ability to operate in a regulated environment; written/spoken/presentation skills.
- Negotiation/influence, project management experience, attention to detail, prioritization.
- Strong teamwork and adaptability across diverse interpersonal styles.
Benefits:
- 401(k) eligibility; pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; certain time off/leave; well-being benefits (EAP, fitness, clubs/activities).
Additional Info:
- Travel less than 5%.