Associate Director - GRA, Global Regulatory Policy & Strategy

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.

Global Regulatory Policy & Strategy strives to enable Lilly to deliver innovative regulatory results by identifying policy hurdles and emerging trends, developing advocacy plans built upon science‑based positions, engaging broad partner networks, and ultimately effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of the Associate Director – Global Regulatory Policy & Strategy is to support multiple U.S. regulatory policy campaigns by building Lilly policy positions, assessing and engaging in external stakeholder groups, and representing Lilly on relevant external work groups with the goal of effecting policy change.

• Lead the development of Lilly policy positions in coordination with internal subject matter experts (i.e., problem statements and desired future state)
• Collect data and/or conduct research to support company policy positions
• Perform stakeholder analyses to understand external perspectives on key Lilly policy priorities
• Track, monitor, and provide analysis of relevant regulatory policies, as advised by management
• Monitor the external environment for new regulatory and policy developments and possible implications for Lilly’s positions and connect with internal stakeholders

• Support the development and implementation of tactical policy plans, including a description of both short‑ and long‑term project deliverables
• Contribute to the development and execution of global regulatory policy strategies that align with Lilly’s long‑term business objectives and external policy landscape

• Develop relationships with key external stakeholders to understand their perspectives and advise them regarding Lilly’s positions
• Represent Lilly in external forums, including regulatory agency meetings, trade associations, and policy round tables
• Impact patient outcomes through collaboration across partner groups

• Exemplify Team Lilly behaviors in internal and external interactions
• Model innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers
• Engage in forums that share regulatory information across GRA components and other Lilly teams and business partners

• Bachelor’s Degree in policy, public health, regulatory, clinical, legal, business, research, science or related field
• 2+ years prior regulatory/policy experience
• 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

• Masters, doctorate or advanced degree is preferred
• 3+ years of regulatory/policy experience is preferred
• Travel up to 25%
• This position is based in Lilly’s Washington, DC office or Remote
• Strong interpersonal skills and demonstrated ability to manage external and internal relationships with key stakeholders
• Ability to research and write briefings, positions, and high‑level communication
• Independence, resourcefulness, influence without authority
• Strong communication skills, both verbal and written

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