Associate Director - Global Regulatory Affairs - Product Communications
Eli Lilly and Company
June 24, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Purpose:
Associate Director, Global Regulatory Affairs – Product Communications provides leadership to deliver accurate, balanced, and substantiated product and disease communications for assigned assets, advising on regulatory requirements and expectations for compliant communications.
Responsibilities:
- Serve as regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics and medical/campaign communications.
- Provide prompt, conclusive regulatory advice enabling business decisions.
- Communicate regulator expectations using OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement action knowledge.
- Mitigate business risk by tracking external trends in advertising/promotion/medical communication topics.
- Build relationships with Lilly teams and partner companies to implement appropriate communications.
- Initiate promotional tactic discontinuation plans for regulatory-initiated events.
- Counsel internal partners on OPDP advisory strategy; develop promotional proposals with marketing/agency and quality-review submission documents.
- Interpret OPDP advice with US brand teams and support OPDP interactions.
- Review 2253 promotional material submissions to FDA.
- Collaborate on promotional claims/press/IR materials; lead labeling revisions balancing business impact and regulatory compliance.
- Share key information to support seamless execution of US regulatory strategy.
- Engage cross-organization forums; challenge teams and lead open discussions to reach robust business solutions.
Minimum Qualifications:
- Bachelor’s degree.
- 3+ years of industry experience in drug development and/or commercialization.
- Authorized to work in the US full-time; Lilly does not sponsor visas.
Additional Skills/Preferences:
- Knowledge of FDA procedures/practices (CFR, guidances).
- Ability to influence without authority; deliver complex projects on timeline.
- Strong communication (listening, verbal, written); systematic thinking.
- Teamwork/adaptability.
- Recent experience reviewing prescription drug advertising/promotional materials.
- Awareness of evolving regulatory reform initiatives.
Benefits (if applicable):
- 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance; time off/leave; well-being benefits; possible company bonus.
Application Instructions:
- If you need accommodation to submit a resume, complete https://careers.lilly.com/us/en/workplace-accommodation.
Associate Director, Global Regulatory Affairs – Product Communications provides leadership to deliver accurate, balanced, and substantiated product and disease communications for assigned assets, advising on regulatory requirements and expectations for compliant communications.
Responsibilities:
- Serve as regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics and medical/campaign communications.
- Provide prompt, conclusive regulatory advice enabling business decisions.
- Communicate regulator expectations using OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement action knowledge.
- Mitigate business risk by tracking external trends in advertising/promotion/medical communication topics.
- Build relationships with Lilly teams and partner companies to implement appropriate communications.
- Initiate promotional tactic discontinuation plans for regulatory-initiated events.
- Counsel internal partners on OPDP advisory strategy; develop promotional proposals with marketing/agency and quality-review submission documents.
- Interpret OPDP advice with US brand teams and support OPDP interactions.
- Review 2253 promotional material submissions to FDA.
- Collaborate on promotional claims/press/IR materials; lead labeling revisions balancing business impact and regulatory compliance.
- Share key information to support seamless execution of US regulatory strategy.
- Engage cross-organization forums; challenge teams and lead open discussions to reach robust business solutions.
Minimum Qualifications:
- Bachelor’s degree.
- 3+ years of industry experience in drug development and/or commercialization.
- Authorized to work in the US full-time; Lilly does not sponsor visas.
Additional Skills/Preferences:
- Knowledge of FDA procedures/practices (CFR, guidances).
- Ability to influence without authority; deliver complex projects on timeline.
- Strong communication (listening, verbal, written); systematic thinking.
- Teamwork/adaptability.
- Recent experience reviewing prescription drug advertising/promotional materials.
- Awareness of evolving regulatory reform initiatives.
Benefits (if applicable):
- 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance; time off/leave; well-being benefits; possible company bonus.
Application Instructions:
- If you need accommodation to submit a resume, complete https://careers.lilly.com/us/en/workplace-accommodation.