Senior Regulatory Affairs Director - CVRM

Do you have an extensive experience of regulatory affairs? Would you like to combine your leadership skills with your strategical understanding of regulatory drug development in a global company that follows the science and turns ideas into life changing medicines? Join us at AstraZeneca to discover future treatment of Cardiovascular, Renal and Metabolic diseases!

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.

Global Regulatory Affairs is part of Research and Development (R&D) which drives both early and late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

We provide strategic regulatory expertise and oversight to support the Research, Development and Commercialization of products for the disease area or stages of development within the TA portfolio across both small molecules and biologics and ensure adequate regulatory resource and skills for projects in line with designated disease area portfolio. The Cardiovascular, Renal and Metabolism (CVRM) team is now offering an exciting opportunity for an experienced Senior Regulatory Affairs Director at Global Regulatory Affairs.

The role can be based at one of AstraZeneca's dynamic R&D sites in Gothenburg, Sweden, Cambridge, UK or Gaithersburg, US.



What you'll do

As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will ensure that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. Strategic leadership skills, and a deep understanding of global regulatory science are important qualities as well as knowledge of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.



The role also includes;

* Leading the planning and construction of the global dossier and core prescribing information.
* Conducting regulatory risk planning and mitigation and lead the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement.
* Accountability for the delivery of all regulatory achievements including assessment of the probability of regulatory success together with risk mitigation measures.
* Accountability for product maintenance, supply and compliance activities associated with marketed brands.
* Leading the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
* Partnering with marketing company and regional regulatory affairs staff to influence developing views/mentorship.
* Leading the regulatory staff working, providing leadership and participate in skill-development, coaching, and performance feedback.



Essential for the role

* Advanced degree in a science related field and/or other appropriate knowledge/experience.
* Previous experience in leading Major Health Authority interactions.
* Significant experience or equivalent of regulatory drug development including product approval/launch.
* Expert knowledge of regulatory affairs within one or more therapeutic areas.
* Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
* Experience in relevant therapy area (small molecules & biologics) is preferred.
* Validated leadership and program management experience.
* Ability to think strategically and critically evaluate risks to regulatory activities.
* Ability to work strategically within a complex, business critical and high profile development program.
* Successful contribution to a major regulatory approval at a global level.
* A scientific and clinical understanding of the regulatory sciences.
* Must demonstrate proficiencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.



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 no later than June 30th, 2020.



Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/



Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html

Culture and atmosphere of the Gothenburg site: https://www.linkedin.com/feed/update/urn:li:activity:6496327311678410752/