Global Regulatory Lead: Strategy & FDA Leadership

Eli Lilly and Company; Indiana; In loco; USD 176.000 - 257.000; Tempo pieno

Vantaggi offerti da questo lavoro

Travel 10-15%

Relocation assistance

Visa/work authorization support (for内部

Descrizione del lavoro

Eli Lilly and Company, based in Indianapolis, IN, seeks a Global Regulatory Lead to define and execute global regulatory strategies, guiding development programs from inception through lifecycle. You will manage regulatory strategies, oversee FDA submissions, and partner with cross‑functional teams to navigate complex regulatory environments.

The role requires 8+ years in regulatory affairs or drug development, and an advanced degree is preferred.

Competenze

• Bachelor’s Degree required.
• 8+ years of experience in regulatory affairs and/or drug development.
• Advanced degree (Master’s, PharmD, PhD) preferred with 8+ years experience.

Mansioni

• Develop and execute global regulatory strategies for portfolios from entry to end of life.
• Lead regulatory representation on cross‑functional teams and programs.
• Oversee US FDA submissions and agency interactions including INDs, NDAs, and BLAs.
• Mentor and lead the Global Regulatory Team to ensure alignment with global strategy.

Conoscenze

Regulatory affairs

Drug development

Leadership

Stakeholder communication

Formazione

Bachelor's Degree

Advanced scientific degree

Descrizione del lavoro

Eli Lilly and Company, based in Indianapolis, IN, seeks a Global Regulatory Lead to define and execute global regulatory strategies, guiding development programs from inception through lifecycle. You will manage regulatory strategies, oversee FDA submissions, and partner with cross‑functional teams to navigate complex regulatory environments.

The role requires 8+ years in regulatory affairs or drug development, and an advanced degree is preferred.