Senior Manager, Regulatory Compliance Management Office
1 month ago
Alexion 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.
As 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.
Strategic 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.
Prioritize work and develop talent within the team to support innovation and benefits realization from digital transformation.
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.
Experience: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.Broad functional knowledge of pharmaceutical sciences, the biopharmaceutical industry, publishing activities, and digital tools relevant to regulatory information management.
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. 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. 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. 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.
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