Associate - Labeling Implementation - North America
Eli Lilly and Company
September 03, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Associate – Global Regulatory Affairs (GRA) Labeling Implementation (North America)
Responsibilities
- Lead/partner/influence labeling implementation activities across the product lifecycle to meet regulator and internal timelines.
- Function as delegate for affiliate labeling implementation responsibilities.
- Lead and monitor implementation of updated/new labeling components into the market.
- Advise affiliates on control and integrity of affiliate truth copy documents.
- Coordinate cross-functionally on multiple simultaneous changes (e.g., GRA-CMC or site technical changes impacting labeling).
- Oversee proof copy approval process with PPD; train/assist affiliates on tools/systems/processes.
- Serve as power user for key labeling systems (e.g., BLUE, RIM).
- Support deviations, escalations, and audits related to labeling implementation.
- Monitor new regulations/guidance for assigned region; assess impact and track progress.
Qualifications
- Bachelor’s degree.
- 3–5 years in biotechnology or pharmaceutical industry.
- Authorized to work in the U.S. full-time (Lilly does not sponsor visas).
Preferred/Additional
- Scientific/health sciences degree (or equivalent), knowledge of local regulatory procedures, manufacturing/supply chain and drug development, project management.
- Ability to lead/influence cross-functionally; strong communication (writing/presenting/listening); strong computer skills; attention to detail.
Benefits (summary)
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave, and well-being benefits.
Application instructions
- N/A
Responsibilities
- Lead/partner/influence labeling implementation activities across the product lifecycle to meet regulator and internal timelines.
- Function as delegate for affiliate labeling implementation responsibilities.
- Lead and monitor implementation of updated/new labeling components into the market.
- Advise affiliates on control and integrity of affiliate truth copy documents.
- Coordinate cross-functionally on multiple simultaneous changes (e.g., GRA-CMC or site technical changes impacting labeling).
- Oversee proof copy approval process with PPD; train/assist affiliates on tools/systems/processes.
- Serve as power user for key labeling systems (e.g., BLUE, RIM).
- Support deviations, escalations, and audits related to labeling implementation.
- Monitor new regulations/guidance for assigned region; assess impact and track progress.
Qualifications
- Bachelor’s degree.
- 3–5 years in biotechnology or pharmaceutical industry.
- Authorized to work in the U.S. full-time (Lilly does not sponsor visas).
Preferred/Additional
- Scientific/health sciences degree (or equivalent), knowledge of local regulatory procedures, manufacturing/supply chain and drug development, project management.
- Ability to lead/influence cross-functionally; strong communication (writing/presenting/listening); strong computer skills; attention to detail.
Benefits (summary)
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave, and well-being benefits.
Application instructions
- N/A