Senior Global Regulatory Counsel – Pharma & Devices

Eli Lilly and Company; Indianapolis (IN); On-site; USD 230,000 - 337,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Job summary

Lilly is seeking an Associate Vice President, Assistant General Counsel, Global Regulatory Legal to provide strategic regulatory guidance for drugs, devices, and diagnostics. You will influence across a matrixed organization, leading regulatory strategy, due diligence, and policy responses.

Requirements include a JD, bar admission, 10+ years in pharma regulatory law, and strong communication with senior leadership. Remote or Indianapolis base with travel.

Qualifications

• Bachelor’s degree and Juris Doctor (or equivalent)
• Licensed to practice law in at least one US jurisdiction
• Minimum 10 years of experience in pharmaceutical regulatory law in law firms or in-house
• Broad regulatory legal subject matter expertise spanning product lifecycle
• Proven ability to manage a substantive and complex legal portfolio independently
• Strong judgment and ability to navigate novel regulatory issues across domains

Responsibilities

• Provide strategic, solutions-oriented legal counsel across regulatory portfolio for drugs, devices, and diagnostics
• Advise on FDA regulatory engagement strategy and pre-submission meetings
• Advise on regulatory strategy for acquisitions, in-licensing, and asset transfers
• Integrate regulatory, litigation, and enforcement risk perspectives into advice
• Monitor and translate evolving global regulatory laws into strategic recommendations
• Represent Lilly in regulatory policy initiatives and respond to agency requests for public comment

Skills

Regulatory law

FDA regulatory

Cross-functional leadership

Communication skills

Mergers & acquisitions

Regulatory strategy

Litigation coordination

Education

Juris Doctor

Bachelor's degree

Job description

Lilly is seeking an Associate Vice President, Assistant General Counsel, Global Regulatory Legal to provide strategic regulatory guidance for drugs, devices, and diagnostics. You will influence across a matrixed organization, leading regulatory strategy, due diligence, and policy responses.

Requirements include a JD, bar admission, 10+ years in pharma regulatory law, and strong communication with senior leadership. Remote or Indianapolis base with travel.