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Associate Vice President – Assistant General Counsel, Infectious Disease & Vaccines, Regulatory Legal
Eli Lilly and Company. Serve as Lilly's dedicated regulatory legal lead for its infectious disease and vaccines portfolio and support other emerging therapeutic areas .
Posted 9/25/2026full-timeIndianapolis • District of Columbia • United StatesSeniorLead💰 $234,000 - $343,200 per yearWebsite
About the role
Key responsibilities & impact- Serve as Lilly's dedicated regulatory legal lead for its infectious disease and vaccines portfolio and support other emerging therapeutic areas
- Provide day-to-day and strategic legal counsel on vaccine-specific regulatory pathways globally
- Extend regulatory legal support to additional emerging therapeutic areas as assigned
- Lead regulatory legal strategy for interactions with global health authorities, including regulatory issues, inspections, enforcement matters, dispute resolution, and significant agency engagements
- Advise on advisory committee strategy and immunization policy dynamics, including ACIP
- Monitor evolving laws, regulations, and guidance applicable to vaccines and biologics
- Partner with senior leaders across Clinical Development, Regulatory Affairs, Manufacturing & Quality, Patient Safety, Commercial, Policy, and Legal
- Lead regulatory legal workstreams for integration of newly acquired assets and platforms
- Build and scale the regulatory legal capability, including governance models and external counsel strategy
- Lead implementation and execution of regulatory legal support across clinical development, pharmacovigilance, and manufacturing/quality
- Deliver integrated legal guidance to key functions in a complex, matrixed environment
Requirements
What you’ll need- Bachelor's Degree
- JD (U.S) or equivalent qualifying law degree from outside of US (e.g., LL.B.) that enables entry into legal practice in the local jurisdiction
- Licensed to practice law in one of the 50 US states
- A minimum of 7-10 years of overall legal experience, including substantial experience advising on biologics regulatory matters
- Prior in-house experience supporting vaccine development or commercialization, or equivalent law firm experience with vaccine manufacturer clients
- Authorized to work in the United States on a full-time basis; Lilly will not provide support for or sponsor work authorization or visas
- Demonstrated ability to lead sophisticated, high-stakes regulatory legal matters with limited precedent and significant ambiguity
- Highly motivated self-starter with the drive to build a legal function in a new business area
- Excellent judgment and strong interpersonal skills
- Familiarity with vaccine-specific legal frameworks including VICP, PREP Act/CICP, VFC Program, BARDA contracting, and ACIP recommendation mechanics and legal consequences
- Experience advising on vaccine clinical trials and clinical trial safety, including trial design, informed consent, data safety monitoring, and adverse event reporting
- Experience advising on biologics manufacturing compliance
- Prior regulatory agency experience
- Experience advising on global vaccine regulatory submissions across multiple jurisdictions, including the EU, Japan, Switzerland, Brazil, and Canada
Benefits
Comp & perks- Company bonus depending, in part, on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision and prescription drug benefits
- Healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities