Senior Director, Regulatory Policy

Senior Director, Regulatory Policy & Portfolio - Canada page is loaded## Senior Director, Regulatory Policy & Portfolio - Canadalocations: CA: Ontario Remotetime type: Full timeposted on: Posted Todayjob requisition id: R-99066At 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.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 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.This role is eligible for additional forms of compensation, such as participation in the Lilly Bonus Program.This posting is for an existing vacancy.**Responsibilities**The Senior Director, Regulatory Policy & Portfolio – Canada, is responsible for leading the development and execution of science-based and efficient regulatory policy initiatives as well as managing regulatory strategy and portfolio for Lilly’s Canadian affiliate**.** This role will develop and advocate for regulatory policy positions, engage with Health Canada, trade associations, and cross-functional partners, and represent Lilly in external workgroups with the goal of leading regulatory policy change in Canada and beyond. Also, this role will provide regulatory leadership and strategic direction to support all regulatory activities within the Canadian affiliate, build technical regulatory expertise and a strong understanding of Lilly’s product portfolio and processes, and collaborate with corporate and external partners using global regulatory tools and databases to achieve business and regulatory objectives. They will provide regulatory leadership, expert guidance, and strategic direction to the Canadian affiliate, support all regulatory activities carried out by the affiliate. Success in this role requires strong leadership, strategic thinking, and the ability to work effectively across teams and with external stakeholders to advance regulatory policy and portfolio management in Canada.**Regulatory Policy - Canada (Lead Multiple Policy Campaigns, approximately 67 percent)*** Lead regulatory policy campaigns in Canada, consistent with Lilly GRPS priorities, focusing on advancing regulatory convergence and harmonization with global standards to enable simultaneous medicine development, submissions, approvals, and launches.* Anticipate, identify, and solve complex policy and technical issues affecting the Canadian regulatory environment.* Own the development of Lilly’s Canadian regulatory policy position papers in coordination with internal and regional subject matter experts (problem statements and desired future state).* Develop Lilly’s input to enhance current and draft Canadian regulations, guidelines, free trade agreements, and public consultations.* Collaborate cross-functionally (e.g., corporate affairs, legal, safety, medical) to progress regulatory policies supportive of regulatory science and Lilly’s innovation strategy.* Collect data and conduct research to support company policy positions; perform stakeholder analyses to understand external perspectives on key Lilly policy priorities in Canada.* Track, monitor, and provide analysis of relevant Canadian regulatory policies, as directed by management.* Lead the development and implementation of tactical policy plans, including both short- and long-term project deliverables.**Regulatory Strategy & Portfolio Management - Canada (approximately 33 percent)*** Oversee the regulatory portfolio for the Canadian affiliate, ensuring alignment with global and regional priorities; monitor progress, risks, and opportunities and communicate these to senior leadership.* Develop and implement Canadian regulatory strategies that support product development, submissions, and lifecycle management, in close coordination with Health Canada and internal teams.* Collaborate closely with the Americas regional regulatory science team and the Canadian affiliate to ensure strong governance, connectivity, and best-practice sharing across policy and portfolio activities.* Facilitate information flow and strategic alignment between the Canadian affiliate, Ottawa, and the Americas team; serve as a connector to integrate policy insights with portfolio decision-making.* Provide strategic regulatory consult to Canadian affiliate leadership, GRA Regional Regulatory scientists, and regulatory functional support groups on a broad range of regulatory topics and process requirements.* Represent the regulatory function and contribute cross-functionally to ensure timely progress of projects and initiatives in line with Canada business priorities and regulatory plans.* Ensure periodic metrics reports of the regulatory forecast vs. business plan to Canda affiliate management.**Exert External Influence*** Propose and deliver to regulators and other stakeholders key messages and communication plans that advance the adoption of Lilly’s Canadian policy positions.* Identify long- and short-term regulatory, competitive, and environmental trends and effectively communicate implications to internal collaborators, including leadership.* Evaluate new regulatory and policy developments and play a direct role in influencing Canadian regulations or strategies.* Develop relationships with key external stakeholders (e.g., Health Canada, trade associations) to understand their perspectives and inform them regarding Lilly’s positions; participate and represent Lilly in Canadian regulatory policy and regulatory intelligence forums.* Impact patient outcomes through collaboration across partner groups.**Effectively Lead, Engage, and Partner*** Model leadership behaviors and regulatory excellence attributes; communicate best practices broadly across teams.* Demonstrate impact across multiple functions and geographic areas; influence senior management, regulators, and external partners on key regulatory policy decisions.* Make complex technical or business decisions within general functional, company, and industry guidelines.* Lead large-scale regulatory policy and portfolio projects to achieve critical policy-shaping objectives.* Contribute to forums that share regulatory information across global regulatory components and other Lilly teams and business partners.**Reporting Structure*** Reports to: Senior Director – Global Regulatory Policy & Strategy – Americas.* Collaborates with: Corporate Affairs Leader in Canada, Canadian Medical Director, and Americas regional regulatory science leadership and Global Regulatory Policy and Strategy.**Basic Qualifications*** Bachelor of Science or Bachelor of Arts in policy, public health, regulatory, clinical, legal, business, research, or related field; master’s or doctorate preferred.* Minimum five years’ experience in Canadian regulatory affairs, regulatory policy, or relevant government/industry roles.* Strong interpersonal#J-18808-Ljbffr