Associate Vice President, Assistant General Counsel, Regulatory Legal Team – Americas Region

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.

This position will be part of the Regulatory Legal Team (RLT), which reports up through Lilly’s General Counsel and works across Lilly Legal and the Company with a highly cross‑functional approach. RLT maintains core legal expertise on clinical development, registration and regulatory matters and works together with other legal teams to provide comprehensive and strategic solutions for the business. RLT also provides regulatory law advice to Global Regulatory Affairs, Manufacturing & Quality, Global Patient Safety, Clinical Development and other functions and teams.

The primary responsibility of this position is to provide legal advice regarding regulations and strategy on drug, medical device (software and hardware) and diagnostic matters for the US and other Americas Region countries (includes Brazil, Mexico and Canada). This will involve leveraging advice through collaboration with Lilly lawyers who work directly with product teams and business affiliates as well as outside counsel as required.

• Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory submissions in the US and other Americas Region countries.
• Provide legal counsel that ensures Lilly development programs incorporate the latest and cutting‑edge interpretations of applicable laws, regulations, guidance, and harmonized standards.
• Stay current on the latest drug, medical device and diagnostics laws, regulations and guidance documents, including recently passed or implemented and emerging laws and regulations.
• Influence internal and external stakeholders regarding key policy initiatives including participation at select trade association meetings and other external activities.
• Provide legal support to the Global Regulatory Strategy Teams and Americas Regional Regulatory Team and related policy groups regarding policy and legislative issues related to drugs, medical devices and diagnostics.
• Maintain and improve an understanding of the clinical and regulatory submissions process and regulatory structures in the US and other Americas Region countries.
• Liaise and partner with International Business Unit representatives and legal teams to ensure appropriate connections are in place to facilitate one‑voice counseling.

• Bachelor’s and Juris Doctorate Degrees
• Licensed to practice law in at least one of fifty states
• Demonstrated expertise in the law and regulations pertaining to pharmaceuticals, medical devices and diagnostics in the US and at least one additional key market in the Americas Region
• Minimum of 5‑7 years’ experience as a lawyer in a law firm, or as an in‑house lawyer in a pharmaceutical company, where candidate’s primary focus was pharmaceutical law.
• Minimum 7‑10 years of overall experience in a law firm or as an in‑house lawyer in a device or pharmaceutical company.
• Qualified candidates must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

• Experience counseling on drug regulatory matters in Canada, Brazil and Mexico
• Prior regulatory agency experience
• Ability to navigate across different country/cultural contexts
• Demonstrated leadership and effectiveness in working with senior leadership
• Highly motivated and collaborative partner with strong interpersonal skills and the ability to work effectively with team members, other lawyers, and members of management across all levels of the Company
• Good judgment and meticulous level of attention to detail
• Excellent…