Eli Lilly and Company
Pharmaceuticals
Eli Lilly and Company is a pharmaceutical company that engages in the discovery, development, and marketing of products in the pharmaceutical industry. The company's mission is to make life better for people around the world by discovering, developing, and delivering innovative human medicines.
Associate Vice President, Assistant General Counsel, Regulatory Legal Team
Job not on LinkedIn
3 days ago
Eli Lilly and Company
Pharmaceuticals
Eli Lilly and Company is a pharmaceutical company that engages in the discovery, development, and marketing of products in the pharmaceutical industry. The company's mission is to make life better for people around the world by discovering, developing, and delivering innovative human medicines.
📋 Description
• Provide legal advice regarding regulations and strategy on drug, medical device (software and hardware) and diagnostic matters for the Asia-Pacific Region (China, Japan, Korea, Australia, Taiwan and other jurisdictions). • Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory submissions. • Provide legal counsel that ensures Lilly clinical 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 Asia-Pacific Regional Regulatory Team and related policy groups regarding Asia-Pacific country 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 Asia-Pacific countries. • Liaise and partner with International Business Unit representatives and legal teams to ensure appropriate connections are in place to facilitate one-voice counseling
🎯 Requirements
• Bachelor’s and Juris Doctorate (or equivalent) Degrees • Licensed to practice law • Demonstrated expertise in the law and regulations pertaining to pharmaceuticals, medical devices and diagnostics in China, Japan and other key markets in the Asia-Pacific 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 legally authorized to be employed in their country of residence.
🏖️ Benefits
• Remote/hybrid work may be acceptable • 10-15% travel is expected, with travel to Lilly’s corporate headquarters located in Indianapolis, Indiana, United States at least 1x/year
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