Global Regulatory Affairs: Product Communications Lead

Eli Lilly and Company; Indianapolis (IN); On-site; USD 132,000 - 194,000; Full time

Benefits offered by this job

Bonus

Comprehensive benefits

401(k)

Job summary

Eli Lilly and Company is seeking an Associate Director of Global Regulatory Affairs - Product Communications to lead and influence the regulatory review of promotional materials and communications for assigned assets. You will collaborate with Regulatory Scientists, US brand teams and FDA OPDP to ensure compliant, accurate messaging.

The role emphasizes strategic advisory support, risk mitigation, and cross-functional leadership to balance regulatory compliance with business needs.

Qualifications

• Bachelor's Degree required.
• 3+ years of industry-related experience in drug development and/or commercialization.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas.

Responsibilities

• Serve as regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics and campaigns.
• Provide high-quality regulatory advice enabling informed business decisions.
• Interpret OPDP feedback and FDA regulatory expectations for compliant communications.
• Lead labeling revisions in collaboration with Regulatory Scientists and Labeling Operations.
• Engage in forums to share regulatory information and influence cross-functional teams.
• Provide timely and high-quality reviews of submissions to FDA.

Skills

Regulatory affairs

Communication

Influence without authority

Project management

FDA regulations

Team collaboration

Education

Bachelor's degree

Job description

Eli Lilly and Company is seeking an Associate Director of Global Regulatory Affairs - Product Communications to lead and influence the regulatory review of promotional materials and communications for assigned assets. You will collaborate with Regulatory Scientists, US brand teams and FDA OPDP to ensure compliant, accurate messaging.

The role emphasizes strategic advisory support, risk mitigation, and cross-functional leadership to balance regulatory compliance with business needs.