AVP, Asst General Counsel, Global Regulatory Legal
Eli Lilly and Company
August 22, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Associate Vice President, Assistant General Counsel – Global Regulatory Legal
Responsibilities:
- Provide strategic, solutions-oriented legal counsel across a global regulatory portfolio for drugs, devices, and diagnostics.
- Counsel Global Regulatory Affairs (GRA) across the product lifecycle (registration through post-market risk management) for pharmaceutical and medical device products.
- Advise on FDA regulatory engagement strategy (pre-submission meetings, information request responses, enforcement interactions) and support submissions to other global health authorities as needed.
- Advise on regulatory strategy for acquisitions, in-licensing, and asset transfers (regulatory due diligence and post-close integration).
- Integrate regulatory, litigation, and enforcement risk perspectives with cross-functional legal teams to anticipate and mitigate emerging risks.
- Monitor evolving global regulatory laws/guidance/enforcement trends and translate into recommendations.
- Represent Lilly in industry forums/trade associations/regulatory policy initiatives; draft and coordinate public comment responses.
Basic Requirements:
- Bachelor’s degree and Juris Doctor (or equivalent).
- Licensed to practice law in at least one US jurisdiction.
- 10+ years in law firm or in-house role in a pharmaceutical/life sciences company (primary focus: pharmaceutical regulatory law).
- Broad regulatory legal expertise across the product lifecycle; experience engaging global health authorities.
- Ability to manage a complex legal portfolio independently.
- Strong judgment; solutions-oriented, business-enabling approach.
- Enterprise mindset; trusted relationship-building; excellent written/verbal communication; handle confidential/privileged information.
Additional Skills/Preferences:
- FDA/EMA (or similar) regulatory agency experience; M&A regulatory due diligence; environmental regulatory familiarity for pharma manufacturing; device/combination product experience; AI/automation governance experience.
- Experience leading through influence in a matrixed, global organization; mentoring/people leadership (if role evolves).
Compensation/Benefits (as stated):
- Anticipated wage: $229,500–$336,600; eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, and medical/dental/vision.
- Remote or Indianapolis HQ; travel 10–15%.
Responsibilities:
- Provide strategic, solutions-oriented legal counsel across a global regulatory portfolio for drugs, devices, and diagnostics.
- Counsel Global Regulatory Affairs (GRA) across the product lifecycle (registration through post-market risk management) for pharmaceutical and medical device products.
- Advise on FDA regulatory engagement strategy (pre-submission meetings, information request responses, enforcement interactions) and support submissions to other global health authorities as needed.
- Advise on regulatory strategy for acquisitions, in-licensing, and asset transfers (regulatory due diligence and post-close integration).
- Integrate regulatory, litigation, and enforcement risk perspectives with cross-functional legal teams to anticipate and mitigate emerging risks.
- Monitor evolving global regulatory laws/guidance/enforcement trends and translate into recommendations.
- Represent Lilly in industry forums/trade associations/regulatory policy initiatives; draft and coordinate public comment responses.
Basic Requirements:
- Bachelor’s degree and Juris Doctor (or equivalent).
- Licensed to practice law in at least one US jurisdiction.
- 10+ years in law firm or in-house role in a pharmaceutical/life sciences company (primary focus: pharmaceutical regulatory law).
- Broad regulatory legal expertise across the product lifecycle; experience engaging global health authorities.
- Ability to manage a complex legal portfolio independently.
- Strong judgment; solutions-oriented, business-enabling approach.
- Enterprise mindset; trusted relationship-building; excellent written/verbal communication; handle confidential/privileged information.
Additional Skills/Preferences:
- FDA/EMA (or similar) regulatory agency experience; M&A regulatory due diligence; environmental regulatory familiarity for pharma manufacturing; device/combination product experience; AI/automation governance experience.
- Experience leading through influence in a matrixed, global organization; mentoring/people leadership (if role evolves).
Compensation/Benefits (as stated):
- Anticipated wage: $229,500–$336,600; eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, and medical/dental/vision.
- Remote or Indianapolis HQ; travel 10–15%.