Senior Global Regulatory Strategy Director (Remote)

Eli Lilly and Company; Indianapolis (IN); Remote; USD 194,000 - 398,000; Full time

Benefits offered by this job

Bonus potential

Comprehensive benefits

Job summary

Lilly seeks a Senior/Executive Director, Global Regulatory Strategy, to lead regulatory programs from development through registration. This role requires strategic leadership across global development, liaison with FDA/EMA, and management of regulatory sub-teams and vendors.

The position is remote in the United States with occasional travel. A strong track record in NDA/IND submissions and cross-functional leadership is essential for success in this fast-paced environment.

Qualifications

• 12+ years of progressive regulatory affairs experience in pharma/biotech.
• 5+ years in global regulatory leadership.
• Experience leading NDA/IND submissions and regulatory strategy.

Responsibilities

• Serve as Global Regulatory Lead for development programs from early development through registration.
• Develop and execute global regulatory strategies across regions and health authorities.
• Lead planning, preparation, and submissions of major regulatory filings (INDs, NDAs, etc.).
• Represent the company in regulatory interactions with FDA, EMA, and other authorities.
• Provide regulatory guidance to cross-functional teams and align stakeholders on development plans.

Skills

Regulatory affairs leadership

NDA/IND submissions

FDA/EMA experience

Cross-functional leadership

People management

Global regulatory strategy

CNS experience

Education

Bachelor's degree in a scientific field

Advanced degree (PhD/PharmD/MS/JD)

Job description

Lilly seeks a Senior/Executive Director, Global Regulatory Strategy, to lead regulatory programs from development through registration. This role requires strategic leadership across global development, liaison with FDA/EMA, and management of regulatory sub-teams and vendors.

The position is remote in the United States with occasional travel. A strong track record in NDA/IND submissions and cross-functional leadership is essential for success in this fast-paced environment.