Associate Director - Global Regulatory Affairs - Product Communications
Eli Lilly and Company
June 24, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Responsibilities:
- Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics, internal field-based communications, medical affairs communications, and media event campaign tactics.
- Provide accurate, prompt regulatory advice enabling informed business decisions.
- Communicate OPDP/FDA regulatory expectations using Lilly OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement knowledge.
- Contribute to business risk mitigation by tracking trends in advertising/promotion/medical communication topics.
- Build relationships with Lilly teams and partner companies to influence compliant communications.
- Initiate promotional tactic discontinuation plans for Regulatory-initiated events.
- Counsel internal partners on OPDP advisory strategy; collaborate with marketing/agency on promotional proposals and review submission documents.
- Interpret OPDP advice and support OPDP interactions with US brand teams.
- Provide timely review of 2253 promotional material submissions to FDA.
- Collaborate with US Regulatory Scientists on promotional claims/strategy, press/IR communications; lead labeling revisions with Labeling Operations to balance business needs and regulatory compliance.
- Engage in forums, constructively challenge teams, and foster open discussions for robust business decisions.
Qualifications:
- Bachelor’s degree.
- 3+ years industry experience in drug development and/or commercialization.
- Must be authorized to work in the US full-time; Lilly will not sponsor work authorization/visas.
Skills/Preferences:
- Knowledge of FDA procedures/practices (CFR, guidances).
- Ability to influence without authority; deliver complex projects on timelines.
- Strong verbal/written communication and active listening.
- Systematic thinking; effective teamwork/adaptability.
- Recent experience reviewing prescription drug advertising/promotional materials.
- Awareness of evolving regulatory reform initiatives.
Benefits/Compensation (if eligible):
- Anticipated wage: $132,000–$193,600; possible company bonus.
- Comprehensive benefits including 401(k), medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instruction:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics, internal field-based communications, medical affairs communications, and media event campaign tactics.
- Provide accurate, prompt regulatory advice enabling informed business decisions.
- Communicate OPDP/FDA regulatory expectations using Lilly OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement knowledge.
- Contribute to business risk mitigation by tracking trends in advertising/promotion/medical communication topics.
- Build relationships with Lilly teams and partner companies to influence compliant communications.
- Initiate promotional tactic discontinuation plans for Regulatory-initiated events.
- Counsel internal partners on OPDP advisory strategy; collaborate with marketing/agency on promotional proposals and review submission documents.
- Interpret OPDP advice and support OPDP interactions with US brand teams.
- Provide timely review of 2253 promotional material submissions to FDA.
- Collaborate with US Regulatory Scientists on promotional claims/strategy, press/IR communications; lead labeling revisions with Labeling Operations to balance business needs and regulatory compliance.
- Engage in forums, constructively challenge teams, and foster open discussions for robust business decisions.
Qualifications:
- Bachelor’s degree.
- 3+ years industry experience in drug development and/or commercialization.
- Must be authorized to work in the US full-time; Lilly will not sponsor work authorization/visas.
Skills/Preferences:
- Knowledge of FDA procedures/practices (CFR, guidances).
- Ability to influence without authority; deliver complex projects on timelines.
- Strong verbal/written communication and active listening.
- Systematic thinking; effective teamwork/adaptability.
- Recent experience reviewing prescription drug advertising/promotional materials.
- Awareness of evolving regulatory reform initiatives.
Benefits/Compensation (if eligible):
- Anticipated wage: $132,000–$193,600; possible company bonus.
- Comprehensive benefits including 401(k), medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instruction:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation