Senior Director, Regulatory Policy & Portfolio

Location: Warman

Senior Director, Regulatory Policy & Portfolio - Canada page is loaded## Senior Director, Regulatory Policy & Portfolio - Canada locations:
CA:
Ontario Remote time type:
Full time posted on:
Posted Todayjob requisition :
R-99066

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.

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 work groups 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…