[Hiring] Associate Vice President, Assistant General Counsel, Global Regulatory Legal @Lilly

Role Description

The Associate Vice President, Assistant General Counsel – Global Regulatory Legal is a senior regulatory attorney and strategic regulatory partner within the Regulatory Legal Team (RLT). The ideal candidate brings deep regulatory legal expertise and the leadership presence to influence across a complex, matrixed organization. RLT is a core strategic partner to the business, providing regulatory legal counsel across the product lifecycle from development through registration, commercialization, and post-market activities.

• Provide strategic, solutions-oriented legal counsel across a broad regulatory legal portfolio including drugs, devices, and diagnostics.
• Serve as legal counsel to Global Regulatory Affairs (GRA), providing strategic and forward-looking legal guidance across the global product lifecycle — from registration through post-market risk management.
• Drive legal advice on FDA regulatory engagement strategy, including pre-submission meetings, information request responses, and enforcement-related interactions.
• Advise on regulatory strategy for acquisitions, in-licensing, and asset transfers, including regulatory due diligence and post-close integration of assets.
• Integrate regulatory, litigation, and enforcement risk perspectives into legal advice, working closely with various legal teams to anticipate and mitigate emerging risks.
• Monitor and interpret evolving global regulatory laws, guidance, and enforcement trends; proactively translate developments into strategic recommendations.
• Represent Lilly’s regulatory legal interests in industry forums, trade associations, and regulatory policy initiatives.

Qualifications

• Bachelor’s degree and Juris Doctor (or equivalent).
• Licensed to practice law in at least one US jurisdiction.
• Minimum 10 years of overall experience in a law firm or as an in-house lawyer in a pharmaceutical or life sciences company, with primary focus on pharmaceutical regulatory law.
• Broad regulatory legal subject matter expertise spanning the product lifecycle and experience engaging with relevant global health authorities.
• Proven ability to manage a substantive and complex legal portfolio independently.
• Strong judgment and the ability to navigate complex, novel legal issues across multiple regulatory domains.
• Enterprise mindset — proactively identifies cross-functional and organizational implications of legal and regulatory issues.
• Highly motivated, dynamic, and collaborative partner with a proven track record of building trusted relationships across all levels of the organization.
• Excellent written and verbal communication skills, with the ability to translate complex regulatory legal issues into clear, actionable guidance.
• Demonstrated ability to appropriately handle highly confidential and privileged information.

Requirements

• Prior regulatory agency experience (e.g., FDA, EMA, or comparable national authority).
• Experience supporting regulatory due diligence in M&A or business development transactions.
• Familiarity with environmental regulatory frameworks relevant to pharmaceutical manufacturing.
• Experience with medical device or drug-device combination product regulatory matters.
• Experience advising on AI/automation governance in a regulated industry context.
• Demonstrated effectiveness leading through influence in a matrixed, global organization.
• Prior mentoring or leadership experience, with willingness to take on formal people leadership responsibilities in the future.

Benefits

• Anticipated wage for this position is $229,500 - $336,600.
• Eligible for a company bonus depending on company and individual performance.
• Comprehensive benefit program including eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits and eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).