Global Regulatory Strategy Lead

BioSpace; Indianapolis (IN); On-site; USD 170,000 - 249,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical benefits

Bonus eligibility

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to drive global regulatory strategy from entry to end of life and to provide strategic/technical leadership to a cross-functional team, including the US FDA interaction plan.

You will oversee US FDA submissions (INDs, NDAs, BLAs), shape development plans, and align affiliate regulatory plans with global strategy, requiring deep regulatory expertise and executive communication.

Qualifications

• Advanced scientific degree (PharmD, PhD) with 8+ years of regulatory affairs and/or drug development.
• Bachelor’s or Master’s degree with 10+ years of regulatory affairs and/or drug development.

Responsibilities

• Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle.
• Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice to drive robust, forward-looking strategies.
• Lead regulatory representation on the GBD/global program team, shaping development plans and providing solutions to regulatory barriers.
• Ensure local affiliate regulatory plans align to global strategy and business priorities - spanning labeling, risk management, and issues management.
• Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs.
• Drive high-quality communications with FDA that clearly articulate Lilly's scientific position.
• Build and leverage productive relationships with FDA to support product registration goals.
• Provide strategic direction to a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global Labeling.
• Foster a culture of transparent communication, feedback, and continuous development.
• Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings.
• Represent GRA at stakeholder and governance meetings; mentor GRA personnel.
• Shape the external regulatory environment by building strategic relationships with key external stakeholders.
• Partner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review press/IR materials.

Education

Advanced scientific degree (PharmD, PhD)

Bachelor’s or Masters and 10+ years of regulatory affairs and/or drug development

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to drive global regulatory strategy from entry to end of life and to provide strategic/technical leadership to a cross-functional team, including the US FDA interaction plan.

You will oversee US FDA submissions (INDs, NDAs, BLAs), shape development plans, and align affiliate regulatory plans with global strategy, requiring deep regulatory expertise and executive communication.