Associate Director, Global Regulatory Affairs, Global Regulatory Policy & Strategy (Remote) at Eli Lilly

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.

Responsibilities

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

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $145,500 - $213,400.

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.