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 related internal/medical affairs communications.
- Provide high quality, prompt, and conclusive regulatory advice to enable informed business decisions.
- Communicate regulatory expectations using OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement actions.
- Contribute to business risk mitigation by monitoring external trends in advertising, promotion, and medical communication topics.
- Build and maintain relationships with Lilly teams and partner companies to influence appropriate communications.
- Initiate promotional tactic discontinuation plans for Regulatory-initiated events.
- Counsel partners on OPDP advisory strategy; collaborate with marketing/agency on promotional proposals; review submission documents.
- Partner with US brand teams to interpret OPDP advice and support OPDP interactions.
- Provide timely review of 2253 promotional material submissions to FDA.
- Collaborate with US Regulatory Scientists on promotional claims strategy and review of press/IR materials.
- Lead labeling revisions with Labeling Operations to balance business implications and regulatory compliance.
- Engage in forums, challenge teams to reach best solutions, and facilitate open discussions.
Minimum Qualifications
- Bachelor’s Degree
- 3+ years industry-related experience in drug development and/or commercialization
- Authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Skills/Preferences
- Knowledge of FDA procedures/practices (CFR, guidances)
- Ability to influence without authority; deliver complex projects on timeline
- Strong communication (verbal/written) and teamwork; systematic thinking
- Recent experience reviewing advertising/promotional materials for prescription drugs
- Awareness of evolving regulatory reform initiatives and changes
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 related internal/medical affairs communications.
- Provide high quality, prompt, and conclusive regulatory advice to enable informed business decisions.
- Communicate regulatory expectations using OPDP feedback, applicable laws/regulations/guidances, and FDA enforcement actions.
- Contribute to business risk mitigation by monitoring external trends in advertising, promotion, and medical communication topics.
- Build and maintain relationships with Lilly teams and partner companies to influence appropriate communications.
- Initiate promotional tactic discontinuation plans for Regulatory-initiated events.
- Counsel partners on OPDP advisory strategy; collaborate with marketing/agency on promotional proposals; review submission documents.
- Partner with US brand teams to interpret OPDP advice and support OPDP interactions.
- Provide timely review of 2253 promotional material submissions to FDA.
- Collaborate with US Regulatory Scientists on promotional claims strategy and review of press/IR materials.
- Lead labeling revisions with Labeling Operations to balance business implications and regulatory compliance.
- Engage in forums, challenge teams to reach best solutions, and facilitate open discussions.
Minimum Qualifications
- Bachelor’s Degree
- 3+ years industry-related experience in drug development and/or commercialization
- Authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Skills/Preferences
- Knowledge of FDA procedures/practices (CFR, guidances)
- Ability to influence without authority; deliver complex projects on timeline
- Strong communication (verbal/written) and teamwork; systematic thinking
- Recent experience reviewing advertising/promotional materials for prescription drugs
- Awareness of evolving regulatory reform initiatives and changes