Associate Director - Global Regulatory Affairs - Product Communications
Eli Lilly and Company
June 24, 2026
Remote friendly (Indiana, United States)
United States
Corporate Functions
Organization Overview:
The purpose of the Associate Director, Global Regulatory Affairs - Product Communications role is to provide leadership and influence to deliver accurate, balanced, and substantiated product and disease communications for assigned assets.
Responsibilities:
- Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics and campaign tactics.
- Provide prompt, conclusive regulatory advice enabling business decisions.
- Communicate regulator expectations using OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement actions.
- Contribute to business risk mitigation by monitoring advertising/promotion/medical communication trends.
- Build and maintain relationships to influence implementation of appropriate communications.
- Initiate promotional tactic discontinuation plans for Regulatory-initiated events.
- Counsel internal partners on OPDP advisory strategy; collaborate on promotional proposals; review submission documents.
- Partner with US brand team to interpret OPDP advice and support OPDP interactions.
- Review 2253 promotional material submissions to FDA.
- Collaborate with US Regulatory Scientists on promotional claims, press/IR communications.
- Lead labeling revisions with Labeling Operations balancing business needs and regulatory compliance.
- Engage in forums, constructively challenge teams, and lead open discussions to reach robust outcomes.
Minimum Qualifications:
- Bachelor’s Degree.
- 3+ years of industry-related experience in drug development and/or commercialization.
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas.
Additional Skills/Preferences:
- Knowledge of FDA procedures and practices (CFR/Guidances).
- Ability to influence without authority; deliver complex projects on timelines.
- Strong communication (active listening, verbal, written).
- Systematic thinking; effective teamwork.
- Recent experience reviewing advertising/promotional materials for prescription drug products.
- Awareness of evolving regulatory reform initiatives/pending changes.
Compensation/Benefits:
- Anticipated wage: $132,000 - $193,600; company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).
Application Instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
The purpose of the Associate Director, Global Regulatory Affairs - Product Communications role is to provide leadership and influence to deliver accurate, balanced, and substantiated product and disease communications for assigned assets.
Responsibilities:
- Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics and campaign tactics.
- Provide prompt, conclusive regulatory advice enabling business decisions.
- Communicate regulator expectations using OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement actions.
- Contribute to business risk mitigation by monitoring advertising/promotion/medical communication trends.
- Build and maintain relationships to influence implementation of appropriate communications.
- Initiate promotional tactic discontinuation plans for Regulatory-initiated events.
- Counsel internal partners on OPDP advisory strategy; collaborate on promotional proposals; review submission documents.
- Partner with US brand team to interpret OPDP advice and support OPDP interactions.
- Review 2253 promotional material submissions to FDA.
- Collaborate with US Regulatory Scientists on promotional claims, press/IR communications.
- Lead labeling revisions with Labeling Operations balancing business needs and regulatory compliance.
- Engage in forums, constructively challenge teams, and lead open discussions to reach robust outcomes.
Minimum Qualifications:
- Bachelor’s Degree.
- 3+ years of industry-related experience in drug development and/or commercialization.
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas.
Additional Skills/Preferences:
- Knowledge of FDA procedures and practices (CFR/Guidances).
- Ability to influence without authority; deliver complex projects on timelines.
- Strong communication (active listening, verbal, written).
- Systematic thinking; effective teamwork.
- Recent experience reviewing advertising/promotional materials for prescription drug products.
- Awareness of evolving regulatory reform initiatives/pending changes.
Compensation/Benefits:
- Anticipated wage: $132,000 - $193,600; company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).
Application Instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation