Regulatory Affairs Associate - Cardiovascular, Renal and Metabolism
Regulatory Affairs Associate - Cardiovascular, Renal and Metabolism
Location: Warsaw, hybrid work (3 days per week from office)
Are you passionate about science and have or would like to get experience withinregulatory affairs? Do you want to be part of across functional and global team, applying youradministrative skillsin ascience focusedenvironment andgrowyourexpertisewithin Regulatory Affairs Management? Then join us to discover future treatmentsofCardiovascular, Renal and Metabolic(CVRM) diseases!
At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positivelyimpactpatients’ lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function,we’refocused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore,learnand 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 nowlooking for anew membersto join our Regulatory Affairs Management team within theCVRM therapeutic areas,in the rolesasRegulatory Affairs Associate (RAA).
Whatyou’lldo
The Regulatory Affairs Associateassistsother members ofRegulatoryAffairs Management group in obtaining andmaintaininglicenses and applicationsin accordance withagreed regulatory strategy and AstraZeneca standards. This role is crucial in ensuring compliance and supporting the regulatory processes that enable our innovative treatments to reach patients.
The CVRM Regulatory Affairs Management group sits within the AstraZeneca Late-Stage Development CVRMorganisationand is accountable forend to enddelivery of regulatory submissions in line with business priorities by providing regulatoryexpertise, efficient projectmanagementand strong leadership.
Yourmainaccountabilities/responsibilities:
Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
Working with setting up submissions in Electronic Regulatory Vault (ERV)
Planning,preparingand executing simple submissions, andassistingwith the preparation and planning of regulatory dispatches.
Be the interface with Health Authority (HA) and its systems for designated regulatory taskse.g.management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number,EudraLinksupport, use of HA Portals.
Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Legal documentatione.g.Letters ofAuthorisation, Powers of Attorney, Translations of regulatory documentation
Provide support across the group for assigned non-drug project roles & responsibilitiese.g.act as a designated point of contact or superuser
Provide coaching, mentoring and knowledge sharing within the RAM skill group
Contribute to process improvement
Do you have the essential qualifications for thisrole?
Excellent written and verbal communication skills
Organized with project management skills
Experience in document management and tracking databases
Aptitude to learn new systems quickly
Cultural awareness
Proficiencywith common document management tools
Ability to work independently and as part of a team
It is an advantage if you have knowledge and experience of:
Relevant qualification and/or experience in science,administrationor IT
1-6 years of relevant experience from biopharmaceutical industry, or other relevant experience
Some regulatory/medical/technical experience
Experience with Veeva Vault
Some regulatory/medical/technical experience
Date Posted
09-Feb-2026Closing Date
19-Feb-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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