Global Regulatory Affairs Lead - Product Communications

Regulatory Toolkit; Indianapolis (IN); On-site; USD 132,000 - 194,000; Full time

Job summary

Lilly, headquartered in Indianapolis, seeks an Associate Director of Global Regulatory Affairs - Product Communications to lead regulatory guidance for promotional materials and disease communications. You will collaborate with Regulatory Scientists, brand teams, and OPDP to ensure compliant, accurate messaging across assets.

Role requires 3+ years in drug development/commercialization, FDA knowledge, and strong communication.

Qualifications

• Bachelor's Degree required.
• 3+ years of industry-related experience in drug development and/or commercialization.
• Authorized to work in the United States full-time; Lilly does not sponsor visas for this role.
• Knowledge of FDA procedures and guidelines (CFR, Guidances).
• Ability to influence without authority and manage complex projects on a timeline.
• Strong written and spoken communication skills.
• Experience reviewing advertising and promotional materials for prescription drug products.
• Awareness of evolving regulatory reform initiatives.

Responsibilities

• Review promotional tactics and communications for US brand teams, Medical Affairs, and Corporate Communications.
• Provide regulatory guidance to enable informed business decisions.
• Interpret OPDP feedback and communicate regulator expectations.
• Partner with US Regulatory Scientist and Labeling Operations to balance business and compliance.
• Lead cross-functional forums and influence key stakeholders to robust outcomes.

Skills

Regulatory guidance

Communication skills

Influence without authority

Project management

Systematic thinking

Team collaboration

Advertising/promotional review

FDA procedures knowledge

Regulatory reform awareness

Education

Bachelor's degree

Job description

Lilly, headquartered in Indianapolis, seeks an Associate Director of Global Regulatory Affairs - Product Communications to lead regulatory guidance for promotional materials and disease communications. You will collaborate with Regulatory Scientists, brand teams, and OPDP to ensure compliant, accurate messaging across assets.

Role requires 3+ years in drug development/commercialization, FDA knowledge, and strong communication.