Global Regulatory Strategy Lead - Early & Late Phase

Regulatory Jobs; Indianapolis (IN); On-site; USD 176,000 - 257,000; Full time

Benefits offered by this job

401(k) plan

Pension benefits

Vacation benefits

Medical/dental/vision coverage

Job summary

Lilly is seeking a Global Regulatory Lead to drive global regulatory strategies from portfolio entry through end of life. You will lead a cross-functional team, serve as the regulatory voice on the Global Brand Development team, and manage interactions with the US FDA.

In this role, you will oversee INDs, NDAs, and BLAs, align global plans with local affiliates, and mentor regulatory staff while shaping external stakeholder relationships and promotional review processes.

Qualifications

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

Responsibilities

• Develop and execute global regulatory strategies, owning the Regulatory Strategy Document from Candidate Selection through end of lifecycle.
• Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs) and communicate regulatory positions clearly.
• Provide strategic direction to a cross-functional Global Regulatory Team and mentor GRA personnel.
• Shape external engagement by building relationships with key stakeholders and advising on regulatory communications.

Skills

Regulatory strategy

FDA interactions

Cross-functional leadership

Stakeholder communications

Risk management

Education

Bachelor’s Degree

Advanced degree (MS/PhD)

Job description

Lilly is seeking a Global Regulatory Lead to drive global regulatory strategies from portfolio entry through end of life. You will lead a cross-functional team, serve as the regulatory voice on the Global Brand Development team, and manage interactions with the US FDA.

In this role, you will oversee INDs, NDAs, and BLAs, align global plans with local affiliates, and mentor regulatory staff while shaping external stakeholder relationships and promotional review processes.