AVP, Asst General Counsel, Global Regulatory Legal

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  Associate Vice President, Assistant General Counsel, Global Regulatory Legal Organization Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. 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. RLT works in close coordination with other legal and risk functions to deliver cohesive, forward-looking guidance that enables innovation while managing legal and regulatory risk.

The primary responsibility of this position is to provide strategic, solutions-oriented legal counsel across a broad regulatory legal portfolio including drugs, devices, and diagnostics. This role requires deep hands-on legal expertise and the ability to build credibility and influence across a complex, matrixed organization. Key responsibilities include but are not limited to: 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 — for pharmaceutical and medical device products. Drive legal advice on FDA regulatory engagement strategy, including pre-submission meetings, information request responses, and enforcement-related interactions, while supporting regulatory submissions to other global health authorities as needed. 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 the Business Unit Legal Team, Product Development Legal, International Business Unit Legal, IP, Litigation, and other colleagues to anticipate and mitigate emerging risks. Monitor and interpret evolving global regulatory laws, guidance, and enforcement trends; proactively translate developments into strategic recommendations for leadership and other internal stakeholders. Represent Lilly’s regulatory legal interests in industry forums, trade associations, and regulatory policy initiatives in coordination with Policy, Legal, and other colleagues, including drafting and coordinating responses to regulatory agency requests for public comment on proposed rules and guidance.

Bachelor’s degree and Juris Doctor (or equivalent) Licensed to practice law in at least one US jurisdiction