Regulatory Intelligence Director

AstraZeneca - Gaithersburg, MD - Regulatory Intelligence Director At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. AstraZeneca's industry-leading Competitive Intelligence and Analysis team sits at the heart of the Biopharmaceuticals R&D Strategy Group and has an impact on decision-making at the highest levels. As a Regulatory function we use our capabilities to accelerate discovery and development, combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients. In our science-led enterprise, we have new, complex and best-in-class products to bring to market and drive fast approvals to play an instrumental role in achieving our aim of getting the right medicines to the right patients, faster than ever before. We are looking for Regulatory Intelligence Directors to join our global teams within Cardiovascular, Metabolic and Renal (CVRM) and Respiratory and Immunology (R&I), at AstraZeneca Biopharmaceuticals R&D. What You'll do You will be part of a high performing R&D Strategy Team, bearing responsibility for ensuring the decisions we make with our pipeline assets best position us for maximum return on investment and positive patient outcomes. As a Regulatory Intelligence Director you will provide disease area specific Regulatory interpretation and impact analysis of emerging competitive intelligence and you will be the central point person within your therapeutic area (TA) Regulatory Affairs group in leading bespoke Regulatory research. Working closely with Vice President, Executive Regulatory Science Directors, Global Regulatory Leaders (GRLs), Regulatory Affairs Directors (RADs), as well as external experts and other Regulatory Policy, Intelligence and Regional Strategy groups (PIRS), you will contribute to our mission by providing Regulatory Intelligence aspects of disease areas and product-specific Regulatory strategies. You will also work closely with International, China, and Japan RADs regarding disease area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease. This is a high impact role that requires you to shape strategy and influence critical investment decisions by delivering industry-leading analysis and insights to ensure a full understanding of the rapidly evolving Biopharmaceuticals landscape. Who you are We are looking for someone who possesses a broad background of experience working in pharmaceutical business, with prior experience in several areas within global regulatory affairs. We would also expect you to be experienced in critically reviewing current global regulatory science trends and challenging the latter with a good understanding of the corresponding scientific and clinical components. Essential for the role An advanced degree in a science-related field is preferred Demonstrated competencies of strategic thinking, data and impact analysis, and excellent oral and written communication skills In-depth knowledge of the designated therapeutic area Have a working knowledge of Regulatory Intelligence Tools and stay up to date with Regulatory news regarding key competitors and the disease area A good understanding of the commercial aspects of drug development Why AstraZeneca? Because innovation is at our heart, we're championing a new mindset for Regulatory. Shifting from conservative to progressive, we look beyond spotting risks, to being solution-oriented. We are pro-actively involved in the strategy, changing the course for approvals and influencing regulators on new technology. Our science-driven approach means our Regulatory strategy is even more appreciated and valued. Here we get to be part of the solution, bringing lifechanging medicines to patients. So, what's next? Are you already imagining yourself joining us? Good, because we can't wait to hear from you! Welcome with your application; CV and cover letter, no later than April 30, 2021 Where can I find out more? Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram BioPharmaceuticals R&D:... - Permanent - Full-time

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