Global Regulatory Affairs Lead — Product Communications

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

Benefits offered by this job

Company bonus

401(k) plan

Medical benefits

Vacation benefits

Flexible spending accounts

Life insurance

Well-being programs

Job summary

Eli Lilly and Company in the United States seeks Associate Director, Global Regulatory Affairs - Product Communications to lead and influence compliant product communications, collaborating with Regulatory Scientists, brand teams, partner companies, and the FDA OPDP to advise on regulatory requirements.

This role requires strong regulatory knowledge and cross-functional leadership to guide promotional strategies, review submissions, and ensure timely, compliant communications across assets.

Qualifications

• Bachelor’s Degree required.
• 3+ years of experience in drug development or commercialization.
• Authorized to work in the United States.
• Knowledge of FDA advertising regulations.

Responsibilities

• Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics and campaigns.
• Provide high quality, prompt regulatory advice to enable informed business decisions.
• Communicate regulator expectations using OPDP feedback and FDA guidelines.
• Contribute to risk mitigation by tracking external advertising and promotion trends.
• Build and maintain relationships with Lilly teams and partner companies to influence communications.
• Initiate promotional tactic discontinuation plans for Regulatory-initiated events.

Skills

Regulatory affairs

Promotional review

FDA/OPDP knowledge

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's Degree

Job description

Eli Lilly and Company in the United States seeks Associate Director, Global Regulatory Affairs - Product Communications to lead and influence compliant product communications, collaborating with Regulatory Scientists, brand teams, partner companies, and the FDA OPDP to advise on regulatory requirements.

This role requires strong regulatory knowledge and cross-functional leadership to guide promotional strategies, review submissions, and ensure timely, compliant communications across assets.