Overview In this role, you will serve as a senior regulatory attorney and strategic partner within Lilly's Regulatory Legal Team, guiding global regulatory matters across the product lifecycle. You will influence a complex, matrixed organization with deep regulatory expertise and credible leadership. You'll shape regulatory strategy, submissions, and enforcement-related interactions while collaborating with cross-functional partners to enable innovation and manage risk. This position offers impact at scale, contributing to life-changing medicines and shaping regulatory policy and strategy.
Compensation / Benefits- bonus program
- 401(k) plan
- pension benefit
- medical, dental, vision insurance
- flexible benefits (FSAs)
- life insurance and disability benefits
Responsibilities- Provide strategic, forward-looking legal counsel to Global Regulatory Affairs across the product lifecycle, from registration to post-market risk management
- Lead FDA regulatory engagement strategy, including pre-submission meetings, information requests, and enforcement interactions; support global regulatory submissions
- Advise on regulatory strategy for acquisitions, in-licensing, and asset transfers, including due diligence and post-close integration
- Integrate regulatory, litigation, and enforcement risk considerations with cross-functional teams to anticipate and mitigate risks
- Monitor evolving global regulatory laws and guidance; translate developments into strategic recommendations for leadership
- Represent Lilly's regulatory interests in industry forums and regulatory policy initiatives; draft responses to public comment on proposed rules and guidance
Key requirements- Bachelor's degree and Juris Doctor (or equivalent)
- Licensed to practice law in at least one US jurisdiction
- Minimum 10 years of regulatory law experience in pharma or life sciences ( law firm or in-house)
- Broad regulatory knowledge across product lifecycle and engagement with global health authorities
- Ability to manage a substantive, complex legal portfolio independently
- Strong judgment and solutions-oriented approach to novel regulatory issues
- Enterprise mindset with cross-functional impact awareness and ability to balance legal with business priorities
- Excellent written and verbal communication skills; ability to simplify complex issues for leadership
- Ability to handle confidential and privileged information appropriately
- collaborative partner
- strong communication
- influential leadership
- regulatory law
- FDA regulatory engagement
- regulatory strategy
