Global Regulatory Strategy Lead

Eli Lilly and Company; Indianapolis (IN); On-site; USD 176,000 - 257,000; Full time

Benefits offered by this job

Travel 10-15%

Job summary

Eli Lilly and Company invites seasoned regulatory leaders to join our Indianapolis-based Global Regulatory Team. As the Global Regulatory Lead, you will steer the development and execution of global regulatory strategies, and serve as the primary regulatory voice for the US FDA and many global authorities.

You will oversee INDs, NDAs, and BLAs, interact with FDA, and align local affiliate regulatory plans with global business priorities. Travel is expected; relocation is provided.

Qualifications

• Bachelor’s Degree required.
• 8+ years of experience in regulatory affairs and/or drug development.
• Experience with regulatory submissions and agency interactions (US FDA).
• Global regulatory knowledge across US, EU, China and Japan.

Responsibilities

• Develop and execute global regulatory strategies and own the Regulatory Strategy Document (RSD).
• Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs).
• Lead a cross-functional Global Regulatory Team and interact with GBD/global program teams.
• Shape external regulatory environment through strategic relationships with stakeholders.

Skills

Leadership

Negotiation

Stakeholder communication

Education

Bachelor's Degree

Advanced degree (MS/PhD)

Job description

Eli Lilly and Company invites seasoned regulatory leaders to join our Indianapolis-based Global Regulatory Team. As the Global Regulatory Lead, you will steer the development and execution of global regulatory strategies, and serve as the primary regulatory voice for the US FDA and many global authorities.

You will oversee INDs, NDAs, and BLAs, interact with FDA, and align local affiliate regulatory plans with global business priorities. Travel is expected; relocation is provided.