Fda Regulatory Attorney Jobs (NOW HIRING)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Associate Vice President, Assistant General Counsel, Global Regulatory Legal
Organization Overview
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.
The Associate Vice President, Assistant General Counsel - Global Regulatory Legal is a senior regulatory attorney and strategic regulatory partner within the Regulatory Legal Team (RLT). The ideal candidate brings deep regulatory legal expertise and the leadership presence to influence across a complex, matrixed organization. RLT 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 works in close coordination with other legal and risk functions to deliver cohesive, forward-looking guidance that enables innovation while managing legal and regulatory risk.
Key Responsibilities
The primary responsibility of this position is to provide strategic, solutions-oriented legal counsel across a broad regulatory legal portfolio including drugs, devices, and diagnostics. This role requires deep hands-on legal expertise and the ability to build credibility and influence across a complex, matrixed organization. Key responsibilities include but are not limited to:

• Serve as legal counsel to Global Regulatory Affairs (GRA), providing strategic and forward-looking legal guidance across the global product lifecycle - from registration through post-market risk management - for pharmaceutical and medical device products.
• Drive legal advice on FDA regulatory engagement strategy, including pre-submission meetings, information request responses, and enforcement-related interactions, while supporting regulatory submissions to other global health authorities as needed.
• Advise on regulatory strategy for acquisitions, in-licensing, and asset transfers, including regulatory due diligence and post-close integration of assets.
• Integrate regulatory, litigation, and enforcement risk perspectives into legal advice, working closely with the Business Unit Legal Team, Product Development Legal, International Business Unit Legal, IP, Litigation, and other colleagues to anticipate and mitigate emerging risks.
• Monitor and interpret evolving global regulatory laws, guidance, and enforcement trends; proactively translate developments into strategic recommendations for leadership and other internal stakeholders.
• Represent Lilly's regulatory legal interests in industry forums, trade associations, and regulatory policy initiatives in coordination with Policy, Legal, and other colleagues, including drafting and coordinating responses to regulatory agency requests for public comment on proposed rules and guidance.

Basic Requirements

• Bachelor's degree and Juris Doctor (or equivalent)
• Licensed to practice law in at least one US jurisdiction
• Minimum 10 years of overall experience in a law firm or as an in-house lawyer in a pharmaceutical or life sciences company, with primary focus on pharmaceutical regulatory law
• Broad regulatory legal subject matter expertise spanning the product lifecycle and experience engaging with relevant global health authorities
• Proven ability to manage a substantive and complex legal portfolio independently
• Strong judgment and the ability to navigate complex, novel legal issues across multiple regulatory domains with a solutions-oriented, business-enabling approach
• Enterprise mindset - proactively identifies cross-functional and organizational implications of legal and regulatory issues, balancing deep functional expertise with broader business priorities
• Highly motivated, dynamic, and collaborative partner with a proven track record of building trusted relationships across all levels of the organization, including senior leadership
• Excellent written and verbal communication skills, with the ability to translate complex regulatory legal issues into clear, actionable guidance
• Demonstrated ability to appropriately handle highly confidential and privileged information

Additional Skills/Preferences

• Prior regulatory agency experience (e.g., FDA, EMA, or comparable national authority)
• Experience supporting regulatory due diligence in M&A or business development transactions
• Familiarity with environmental regulatory frameworks relevant to pharmaceutical manufacturing
• Experience with medical device or drug-device combination product regulatory matters
• Experience advising on AI/automation governance in a regulated industry context
• Demonstrated effectiveness leading through influence in a matrixed, global organization
• Prior mentoring or leadership experience, with willingness to take on formal people leadership responsibilities in the future should the role evolve in that direction

Other Information

• This position may be based at Lilly's corporate headquarters in Indianapolis, Indiana, or performed remotely.
• Ability to travel 10-15%, including travel to Lilly's corporate headquarters in Indianapolis, Indiana if based remotely.

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.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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
$229,500 - $336,600
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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