Roles within Regulatory Affairs at AstraZeneca, CVRM

Regulatory Affairs Manager / Associate Regulatory Affairs Director

Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functional and global? At AstraZeneca, we work at the cutting edge of science to develop the ground-breaking medicines of the future - here we do things that have never been done before. Does this match your skills and ambitions for the future, then join us to discover future treatments of Cardiovascular, Renal and Metabolic (CVRM) diseases!

AstraZeneca's pipeline of innovative medicines is consistently growing within CVRM. Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it - working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we're focused and committed to the development of our products as well as to our people - providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.

We are more than 65.000 people in over 100 countries in AstraZeneca. Our aim is simply to positively impact lives together. Using the power of science and innovation, our people to improve the impact medicine has on patients. Together, we explore the world of science through our remarkable product pipeline and we take our understanding of the CVRM therapeutic area to a whole new level by seeking new treatments.

We are now offering exciting opportunities for talented and highly motivated individuals to join our Regulatory Affairs Management team within the CVRM therapeutic areas as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD).

These roles are based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden.



What you'll do

In your role as RAM/ARAD, you lead the end-to-end planning, coordination and execution of assigned regulatory procedures and submissions. You contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.

The RAM/ARAD works in cross functional teams, with all phases of drug development across geographic regions and is accountable for regulatory project delivery and process improvements in line with business priorities.



Your main accountabilities/responsibilities:

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Lead and/or contribute to the planning, preparation and delivery of submissions of varying complexity throughout the product's life cycle from either a global and/or regional perspective.
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Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g. response documents, study protocols, Periodic Safety Reports
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Analysis of regulatory procedures and special designations used during development, authorizations and extensions of a medicinal product
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Lead multi-disciplinary project teams
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Identify regulatory risks and propose mitigations to appropriate member of cross functional teams.
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Support operational and compliance activities for assigned regulatory tasks



Requirements

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Relevant University Degree in Science or related field
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Minimum 2 years regulatory experience within the biopharmaceutical industry or at a health authority. To qualify for the ARAD position, 4 years' experience of Regulatory Affairs for Medicinal Products in EU, US or other regions.
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Drug development knowledge
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Strong project management skills
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Excellent written and verbal communication skills
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Leadership skills, including experience leading multi-disciplinary project teams
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Cultural awareness in a global company
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Proficiency with common project management and document management tools
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Ability to work independently and well as part of a team
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Ability to analyze problems and recommend actions
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Scientific knowledge in level to understand regulatory issues and facilitate scientific discussions
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Knowledge of the Cardiovascular, Renal and Metabolism therapy area





So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you! Welcome with your application (CV and cover letter) no later than 30 September, 2021.

We will review the applications continuously so please apply as soon as possible.



Where can I find out more?

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

Life in Gothenburg: https://www.movetogothenburg.com/

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