Vice President, Head of Regulatory Legal

Position Overview

• Location Type: Not Specified
• Job Type: Full time
• Salary: Not Specified

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.

We are seeking a dynamic and innovative individual to serve as the Head of Regulatory Legal and lead the Regulatory Legal Team (RLT) at Lilly. This role requires a practical, creative, and collaborative individual with extensive experience in the biopharmaceutical industry with a focus on US FDA and global medicines agencies. The ideal RLT leader has a deep understanding of the relationship between the commercial and the legal aspects related to clinical development, registration, regulatory submissions and approval, and manufacturing matters and works together with other legal teams to provide comprehensive and legal, strategic and pragmatic solutions for the business. This leader will also oversee the team that provides regulatory law advice to Global Regulatory Affairs, Manufacturing & Quality (including Environmental), Global Patient Safety or pharmacovigilance, Clinical Development and other functions and teams.

The ideal candidate will possess over 10 years of experience, preferably in an in-house setting, and will drive regulatory legal strategy and ensure compliance with all applicable laws and regulations.

Key Responsibilities

• Understand regulatory implications and decisions across an innovative biopharmaceutical’s lifecycle and connect Regulatory risks/options with commercial and practical outcomes.
• Monitor and analyze regulatory developments globally, providing strategic advice to anticipate and respond to changes in the regulatory landscape.
• Maintain strong relationships with regulatory authorities and industry organizations to influence regulatory policy and practice.
• Lead and manage the global Regulatory Legal team, providing guidance and support to ensure excellence in regulatory compliance and legal affairs.
• Proven leadership and management of a team, fostering a collaborative and productive work environment.
• Develop and implement regulatory strategies that align with Lilly's business objectives and ensure compliance with global regulations.
• Cultivate relationships with and collaborate with cross-functional teams, including R&D, commercial, and regulatory to provide legal counsel on regulatory matters.
• Advise senior management on regulatory risks and opportunities, ensuring informed decision-making processes.
• Oversee the lawyers that provide advice on the preparation and submission of regulatory documents to health authorities worldwide.
• Ensure the company's operations comply with all relevant laws, regulations, and guidelines, safeguarding Lilly's reputation and interests.
• Oversee and advise on other areas of regulatory law including manufacturing, supply chain, clinical design, clinical trials, and pharmacovigilance.

Qualifications

• Juris Doctor (JD) degree from an accredited law school.
• Minimum of 10 years of experience in the pharmaceutical industry, with a strong preference for in-house pharmaceutical experience.
• Proven track record of developing and implementing effective regulatory strategies.
• Strong understanding of global regulatory frameworks and compliance requirements.
• Excellent written and verbal communication skills with an ability to influence others.
• Demonstrated ability to appropriately handle highly confidential information.
• Demonstrated dedication to expand knowledge and adapt to a changing environment.
• Ability to travel 10-15%, including at least one annual trip to Lilly's corporate headquarters.