Associate Vice President - Global Regulatory Affairs, ...

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. If you are interested in applying for this job, please make sure you meet the following requirements as listed below. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $238,500 - $349,800. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Organization Overview: 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 Vice President - Global Regulatory Affairs, Global Regulatory Policy & Strategy (Genetic Medicine and Neuroscience) role is to elicit, develop, and progress Lilly's genetic medicine and neuroscience regulatory policy positions and related advocacy strategies globally to enable innovation and ultimately improve outcomes for patients. In this role, you will represent Lilly in external consortia and policy-related forums and rely on a strong pre-existing network of external collaborators. Responsibilities: Develop strategies and regulatory policy positions for highly visible genetic medicine and neuroscience projects that have significant business impact on the company. Gain consensus on Lilly's priority global regulatory topics consistent with GRA's overall regulatory policy vision, which will center around topics that encourage innovation in drug development and regulatory review of genetic and neuroscience medicines. Critically review and analyze regulatory and legislative proposals and identify possible policy, political, and financial impact to Lilly in cooperation with cross-functional partners. Articulate regulatory policy challenges, problem statements and desired future states. Identify and develop data and evidence to support company positions, working in collaboration with cross-functional colleagues. Bring in or represent external viewpoints as company positions are developed. Cultivate relationships and collaborate with internal subject matter authorities, including Lilly Neuroscience, Prevail, Akouos, and other Lilly Genetic Medicine colleagues and GRA colleagues including global regulatory leads, among others, to create evidence and science-based policy positions. Build and implement a tactical policy advocacy plan. Impact GRA and across Lilly. Exert External Influence: Create and foster strategic relationships with key regulators and other external players to identify and anticipate opportunities for growth. Anticipate changes in the external environment and develop action plans. Engage on behalf of Lilly in health policy-related forums. Triage opportunities to engage externally so that the appropriate company experts can contribute. Attend and present at key industry conferences to showcase Lilly policy positions. Build upon existing relationships and maintain strong collaborations with external patient/professional groups, think-tanks, academic groups, policy organizations and associations. Impact patient outcomes through collaboration across partner groups. Effectively lead, engage and partner: Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions. Model the 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. Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions. Make significant decisions guided by industry norms and business strategy. Influence senior leadership, regulators, and/or external partners on business and technical decisions that have a critical impact on business direction. Influence innovative thinking across multiple functions, geographies, and/or external organizations. Direct the resolution of highly complex business problems with significant impact, using advanced critical thinking. Basic Qualifications: Master's or Doctorate Degree with a minimum of 10+ years of relevant research, regulatory, policy, and/or advocacy experience. Additional Skills and Preferences: Recognized expertise as an external thought leader in regulatory policy. Established external network in regulatory policy environment. Experience engaging in external consortia and passionate about crafting policy issues. Recognized experience in leading/implementing public policy or regulatory policy campaigns. Previous experience shaping regulatory policy issues related to genetic medicine and/or neuroscience development. Prior work with organizations such as FDA, BIO, Alliance for Regenerative Medicine, and PhRMA. Proficient in researching and writing briefings, positions, and high-level communications for executive staffing. Ability to influence without authority, demonstrate resourcefulness, and operate independently. Additional Information: Travel up to 20%. Position reports to Vice President, Global Regulatory Affairs - Global Regulatory Policy & Strategy with dotted line reporting relationship to Vice President, Regulatory Affairs (Prevail Therapeutics) and Vice President, Global Regulatory Affairs - Global Regulatory Strategy Leader (Neuroscience). Position Location - Indianapolis, IN, Washington, DC, Boston, MA or Remote. 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 (for further assistance. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #J-18808-Ljbffr

Created: 2025-01-01