Regulatory Affairs Manager, CVRM

Do you have in depth knowledge within Regulatory Affairs and want to develop your skills within project management?

At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments of Cardiovascular, Renal and Metabolism diseases.

At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients' lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we're focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore, learn and develop across all regulatory roles and levels, with the aspiration to make AstraZeneca the place to build your career in Regulatory.



The role

We are now seeking a new member to join our Regulatory Affairs Management team within the Cardiovascular, Renal and Metabolism Therapies Areas, in the role as Regulatory Affairs Manager (RAM). This role will be based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work.



What you'll do

In your role as Regulatory Affairs Manager (RAM), 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 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



Essential 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 or other relevant experience
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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 24 April 2022.

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/