Global Regulatory Strategy Leader

Eli Lilly and Company; Indianapolis (IN); On-site; USD 169,500 - 248,600; Full time

Benefits offered by this job

Company bonus

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave

Well-being programs

Job summary

Eli Lilly and Company is seeking a Global Regulatory Lead to oversee the development and execution of global regulatory strategies from portfolio entry through end of life. You will lead a cross-functional team and manage US FDA interactions, shaping development plans and regulatory strategies.

The role requires an advanced scientific degree with 8+ years in regulatory affairs or drug development, plus strong leadership and communication skills for executive audiences. Travel is expected.

Qualifications

• Advanced degree and 8+ years in regulatory affairs or drug development.
• Experience leading global regulatory strategy and cross-functional teams.
• Proven ability to interact with US FDA and other health authorities.

Responsibilities

• Develop and execute global regulatory strategies, owning the RSD from candidate selection to lifecycle.
• Oversee US FDA submissions and agency interactions, including INDs, NDAs, and BLAs.
• Lead a cross-functional Global Regulatory Team and mentor GRA personnel.
• Engage external stakeholders and advise on promotional strategy and communications.

Skills

Regulatory strategy

Global regulatory leadership

US FDA interactions

Cross-functional leadership

Executive communication

Education

Advanced scientific degree (PharmD/PhD)

Bachelor’s/Master’s in a relevant field

Job description

Eli Lilly and Company is seeking a Global Regulatory Lead to oversee the development and execution of global regulatory strategies from portfolio entry through end of life. You will lead a cross-functional team and manage US FDA interactions, shaping development plans and regulatory strategies.

The role requires an advanced scientific degree with 8+ years in regulatory affairs or drug development, plus strong leadership and communication skills for executive audiences. Travel is expected.