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 intelligence groups sit at the heart of the Biopharmaceuticals R&D strategy and impact decision-making at the highest levels. As a Regulatory function, we translate and refine our intelligence from across and outside the business, and combine knowledge from other therapy areas and functions, to develop regulatory strategies and accelerate discovery and development

In our science-led enterprise, we have new, complex, and best-in-class products to bring to market, and fast approvals of competitive labels play an instrumental role in achieving our aim of getting the right medicines to the right patients,

We are looking for Regulatory Intelligence Directors to join our global teams within Cardiovascular, Metabolic and Renal (CVRM) at AstraZeneca Biopharmaceuticals R&D. The position can be located at either of our dynamic R&D sites in Gaithersburg (US), Cambridge (UK) and Gothenburg (Sweden).



What You'll do

You will be part of a high performing regulatory intelligence group within CVRM, 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 and regulatory specific interpretation and impact analysis of emerging competitive intelligence and you will be a central point person within your disease area in leading bespoke research.

Working closely with our Senior Director, Regulatory Intelligence and closely with Vice Presidents, Executive Regulatory Science Directors, Global Regulatory Leaders (GRLs), Regulatory Affairs Directors (RADs), external experts and other Regulatory Policy, Intelligence and Regional Strategy groups (PIRS), you will contribute to multiple robust 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 the overall understanding of the 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 and intelligence work.

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

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An advanced degree in a science-related field is preferred
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Demonstrated competencies of strategic thinking, data and impact analysis, and excellent oral and written communication skills
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In-depth knowledge of the designated therapeutic area
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Have a working knowledge of Regulatory Intelligence Tools and stay up to date with Regulatory news regarding key competitors and the disease area
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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!

If you are interested to know more about us, apply now! We welcome your CV and cover letter no later than September 18th, 2022.