Senior Director - Global Regulatory Affairs - Global Regulatory Lead,
$169,500–$248,600 year
RemoteIndianapolis, Indiana, United States
Job Summary
Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document from candidate selection through end of lifecycle. Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs, while driving high-quality communications to articulate Lilly's scientific position. Lead a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global Labeling, fostering a culture of transparent communication and continuous development. Shape the external regulatory environment by building strategic relationships with key external stakeholders and partnering with Regulatory Product Communications and Global Marketing to advise on promotional strategy. This role requires an advanced scientific degree and 8+ years of regulatory affairs experience, with 10–15% travel expected. Based in Indianapolis, IN, relocation is provided, and the position is full-time.
Required Qualifications
- Advanced scientific degree (i.e. PharmD, PhD)
- 8+ years of experience in regulatory affairs and/or drug development
- Bachelor's or Masters and 10+ years of experience in regulatory affairs and/or drug development
- Deep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development process
- Demonstrated experience with regulatory submissions and agency interactions across US, EU, China, and Japan
- Direct experience in both clinical and CMC regulatory sciences
- Strong leadership, negotiation, and stakeholder communication skills — including executive-level audiences
- Proven ability to assess and manage risk in a highly regulated environment
- Experience in the applicable therapeutic area
- This position is based in Indianapolis, IN and relocation is provided, remote is not available for this role
- Travel expected: 10–15%
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.