Job Description

Location: Mississauga, Canada Job reference: R-199618 Date posted: 05/14/2024Alexion is seeking an experienced and strategic leader to join our team as the Senior Director of Regulatory Operations and Systems (RO&S). This is a pivotal role that offers an opportunity to spearhead the optimization of systems for regulatory submissions and approvals, enhancing our speed to clinical trials and market presence.Position SummaryAs the Senior Director of RO&S, you will provide both strategic and operational leadership in Regulatory Operations, primarily focusing on Regulatory Information Management, as well as publication management. Your role will involve leading a team with a high sense of urgency, providing operational support with digital tools, system integration, and ensuring effective communication and constructive relationships with business partners.Key ResponsibilitiesStrategic Leadership:Set the strategic direction for the development and implementation of new systems to expedite regulatory submissions and approvals.Team Management:Lead cross-functional teams to deliver integrated digital capabilities for data, content, submissions, and knowledge management.Resource Allocation:Manage team resources to align with AstraZeneca\'s regulatory submission and business objectives.Talent Development:Prioritize work and develop talent within the team to support innovation and benefits realization from digital transformation.Organizational Readiness:Develop infrastructure and prepare personnel for maximum adoption and benefit realization from digitalization.Continuous Improvement:Drive the enhancement of systems and processes within Regulatory Affairs.Visionary Leadership:Define the future state of Regulatory Information Management systems for the combined organization, ensuring data governance and compliance.Communication and Stakeholder Management:Provide periodic updates to Alexion Regulatory Affairs leadership and engage in industry forums.Essential QualificationsExperience:At least 10 years in Regulatory Affairs within the biopharmaceutical industry, with a strong record of leading system implementations and cross-functional project teams.Education:BA/BS degree in a scientific discipline, with an MS or Ph.D. preferred.Communication Skills:Exceptional written and oral skills, with an ability to communicate effectively across multiple stakeholders in a cross-functional environment.Industry Knowledge:Broad functional knowledge of pharmaceutical sciences, the biopharmaceutical industry, publishing activities, and digital tools relevant to regulatory information management.Join UsAstraZeneca is a global, innovation-driven biopharmaceutical business. We are dedicated to the discovery, development, and commercialization of prescription medicines for some of the world\'s most serious diseases. By joining us as the Senior Director of RO&S, you\'ll play a vital role in our mission to push the boundaries of science and deliver life-changing medicines. If you are a strategic thinker with a passion for leadership and innovation in the field of Regulatory Affairs, we want to hear from you.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That\'s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\'re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirementsAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Alexion Pharmaceuticals