Regulatory Strategy Jobs in Indiana (NOW HIRING)

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Senior Director- Counsel, Infectious Disease & Vaccines, Regulatory Legal
Organization Overview
This position will be part of the Regulatory Legal Team (RLT), which 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 is a collaborative team of lawyers who collectively maintain the core legal expertise for the Company on global regulatory laws, including clinical development and registration, manufacturing and quality, patient safety, environmental and other areas of law. RLT works in close coordination with Business Unit Legal Teams (BULT), Product Development Legal, International Business Unit Legal (IBU Legal), IP, Litigation, and other legal and risk functions to deliver cohesive, forward-looking guidance that enables innovation while managing legal and regulatory risk.
The Senior Director- Counsel, Infectious Disease & Vaccines, Regulatory Legal will serve as Lilly's dedicated regulatory legal lead for its newly formed infectious disease and vaccines portfolio. This role requires a leader who thrives amid ambiguity; can build legal frameworks where none exist; and who brings the subject matter expertise, strategic vision, and proactive orientation to the role. The candidate will be a builder - not merely a counselor - and will be instrumental in establishing the legal function's role and credibility within this new business area. This is a rare opportunity to shape an emerging franchise from the ground up.
Responsibilities
This position is the senior regulatory legal partner for Lilly's Infectious Disease and Vaccines business, providing solutions-oriented legal counsel across the full product lifecycle, from integration and development through registration, commercialization, and post-market activities. This role operates at the intersection of novel science, high-stakes regulatory environments, and significant opportunities for patients, requiring strong judgment, deep vaccine and infectious disease expertise, and the initiative to lead proactively. While accountable for the execution and implementation of regulatory legal support across the portfolio, this role will work in close partnership with RLT and other legal subject-matter experts .
Key responsibilities include:
Strategic Regulatory Legal Leadership

• Vaccine regulatory strategy:Serve as the primary regulatory legal partner to the Vaccines & Infectious Disease team, providing day-to-day and strategic legal counsel on vaccine-specific regulatory pathways globally.
• Health authority engagement: Lead regulatory legal strategy for agency interactions with global health authorities, including high-profile regulatory issues, inspections, enforcement matters, dispute resolution, and other significant agency engagements.
• Advisory committee and immunization policy: Advise on advisory committee strategy and immunization policy dynamics (e.g., ACIP), in partnership with Policy and Government Affairs.
• Emerging regulatory issues: Maintain strong situational awareness of evolving laws, regulations, and guidance applicable to vaccines and biologics to anticipate and assess risks and opportunities.
• Enterprise leadership: Partner with senior leaders across Clinical Development, Regulatory Affairs, Manufacturing & Quality, Patient Safety, Commercial, Policy, and Legal to shape regulatory strategies for the vaccines and infectious disease portfolio.

Portfolio Integration & Lifecycle Execution

• Portfolio integration: Lead regulatory legal workstreams for the integration of newly acquired assets and platforms; providing tailored, program-specific counsel across all stages of product and platform lifecycle.
• Legal capability building: Build and scale the regulatory legal capability for the portfolio, including governance models and external counsel strategy. Partner across Legal to align support and prepare for portfolio growth.
• Lifecycle execution: Serve as the lead for the implementation and execution of regulatory legal support across the portfolio lifecycle including clinical development, pharmacovigilance, and manufacturing/quality in collaboration with RLT and other legal subject-matter experts.
• Cross-functional partnership: Deliver integrated legal guidance to key functions (Clinical Development, Regulatory Affairs, Patient Safety, Manufacturing & Quality, Commercial, and Policy) while operating as a proactive solutions-oriented partner in a complex, matrixed environment.

Basic Requirements

• Bachelor's Degree
• JD (U.S) or equivalent qualifying law degree from outside of US (ex: LL.B.) that enables entry into legal practice in the local jurisdiction
• Licensed to practice law in one of the 50 US states.
• 5 years plus of overall legal experience, including substantial experience advising on biologics regulatory matters, gained within a regulatory agency, law firm, and/or as in-house counsel at a pharmaceutical or biotechnology company.
• Prior in-house experience supporting vaccine development or commercialization, or equivalent law firm experience with vaccine manufacturer clients.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to
• F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences

• 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, strong interpersonal skills, and the ability to work effectively with team members, other lawyers, and senior management across all levels of the Company
• 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 (e.g., EU, Japan, Switzerland, Brazil, Canada)

Other Information

• Indianapolis or Washington, DC preferred. Remote/hybrid work may be acceptable
• Travel of approximately 10-15% is expected, including travel to Lilly's Indianapolis headquarters

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$195,000 - $286,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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