Global Regulatory Lead: Strategy & FDA Partnership

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 170,000 - 249,000; Full time

Benefits offered by this job

Relocation provided

Bonus eligibility

Excellent benefits

Job summary

Lilly in Indianapolis, Indiana, is seeking a Global Regulatory Lead to guide global regulatory strategies and oversee FDA submissions from early development through lifecycle. You will lead a cross-functional team and manage external stakeholder relationships to ensure successful product registrations.

The role requires an advanced scientific degree with 8+ years in regulatory affairs or equivalent experience, strong leadership, and a track record of strategic regulatory execution across

Qualifications

• Advanced scientific degree (PharmD or PhD) with 8+ years in regulatory affairs and/or drug development.
• Alternatively, Bachelor’s or Master’s with 10+ years in regulatory affairs and/or drug development.
• Deep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development process.
• Strong leadership, negotiation, and stakeholder communication skills including executive-level audiences.

Responsibilities

• Develop and execute innovative global regulatory strategies from Candidate Selection through end of lifecycle.
• Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs) and high-quality FDA communications.
• Provide strategic direction to a cross-functional Global Regulatory Team and mentor personnel.
• Shape external regulatory engagement and collaborate with Regulatory Product Communications to advise on promotional strategy.

Skills

Regulatory affairs

FDA submissions

Cross-functional

Global regulatory

Strategic thinking

Education

PharmD/PhD

Bachelor/Master

Job description

Lilly in Indianapolis, Indiana, is seeking a Global Regulatory Lead to guide global regulatory strategies and oversee FDA submissions from early development through lifecycle. You will lead a cross-functional team and manage external stakeholder relationships to ensure successful product registrations.

The role requires an advanced scientific degree with 8+ years in regulatory affairs or equivalent experience, strong leadership, and a track record of strategic regulatory execution across