ASSOCIATE DIRECTOR, GLOBAL REGULATORY POLICY – LATIN AMERICA, GRA

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Organization Overview.
Global Regulatory Policy and Strategy (GRPS) enables 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, Latin America (LATAM) region is to support science-based and efficient global regulatory policy initiatives in the region by developing Lilly policy positions, assessing, and engaging in external stakeholder groups, and representing Lilly on relevant external work groups with the goal of effecting and leading policy change in the region and beyond.
Responsibilities.
Support Multiple Policy Campaigns Primary geographies of regulatory policy responsibility for this position will be Brazil, Mexico, Colombia, and other markets within the LATAM region.
Primary responsibility will be to enhance regulatory convergence in the region and harmonization across both regional and global regulators.
Enable Lilly to advance global regulatory convergence within LATAM to deliver global simultaneous medicine development, submissions, approvals, and launches.
Support the development of Lilly policy position papers in coordination with internal and regional subject matter experts (i.
., problem statements and desired future state).
Developing and/or coordinating Lilly’s input to enhance current and draft regulations, guidelines, free trade agreements, and public consultations.
Collaborating cross-functionally (e.
., corporate affairs, legal, safety) to progress regulatory policies supportive of regulatory science and Lilly’s innovation strategy.
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 directed by management.
Monitor the external environment for new regulatory and policy developments and possible implications on Lilly’s positions and communicate with internal stakeholders.
Support the development and implementation of tactical policy plans, including a description of both short- and long-term project deliverables.
Exert External Influence Propose key messages and communication plans that advance the adoption of Lilly policy positions.
Develop relationships with key external stakeholders to understand their perspectives and inform them regarding Lilly’s positions.
Participate as a member of trade association teams to leverage Lilly positions.
Participate as a member and represent Lilly in regulatory policy and regulatory intelligence regional forums.
Impact patient outcomes through collaboration across partner groups   Effectively Lead, Engage, and Partner Model leadership behaviors and regulatory excellence attributes.
Engage in forums that share regulatory information across global regulatory components and other Lilly teams and business partners.
Basic Qualifications.
Bachelor of Science or Bachelor of Arts in relevant policy, public health, regulatory, clinical, legal, business, research, or related field; Masters or doctorate preferred.
Five years of prior regulatory and/or regulatory policy experience within a relevant government agency or company.
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 communications.
Independence, resourcefulness, influence without authority.
Strong communication skills, both verbal and written.
Fluency in English, Spanish, and Portuguese.
Location.
This position supports hybrid working in Brasília (optimal location) or São Paulo, Brazil or Mexico City, Mexico.
Travel will be required across the region and to occasional meetings beyond the region.
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