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.

Purpose: 

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.   

Support Multiple Regulatory Policy Campaigns  

• 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 

Develop and Execute Policy Strategy and Plans 

• 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 

Exert External Influence  

• 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 roundtables. 

• Impact patient outcomes through collaboration across partner groups 

Effectively Lead, Engage, and Partner 

• 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 

Minimum Qualification Requirements: 

• 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.

Other Information/Additional Preferences: 

• 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 

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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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