Regulatory Affairs Manager
Regulatory Affairs Manager
Location: Warsaw, hybrid work (3 days per week from office)
At AstraZeneca, we offer you a unique experienceto workincross functional teamswithall 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 toregulatorysubmission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments in theCardiovascular,Renaland MetabolismTherapy Area.
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. Moreover, by introducing a Regulatory academy and laying out a development path, we want to accelerate your professional and personal growth.
The role
We arelooking foramember to join our Regulatory Affairs Management team within theCardiovascular, Renal and Metabolism Therapy Area,in the roleasRegulatory AffairsManager(RAM).
Yourmainaccountabilities/responsibilities:
Leadand /or contribute totheplanning, preparation, and delivery of submissions of varying complexity throughout the product’s life cycle from either a global and/or regional perspective.
Develop,executeandmaintainsubmissiondelivery plans, submission content plans, and proactively provide status updates todesignatedstakeholders.
Provide regulatory input/expertiseon 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
Lead multi-disciplinary project teams
Support operational and compliance activities for assigned regulatory tasks
Provide coaching, mentoring and knowledge sharing within the regulatory skill group
Contribute to and lead process improvement
Identifyregulatory risks and propose mitigations to appropriate member of cross functional teams
Requirements:
- University degree in science or a related field
- Deep understanding of and proven experience from Regulatory Affairs, within the biopharmaceutical industry and/or at a health authority
- Extensive knowledge of the drug development process
- Project management skills
- Leadershipsskills
- Excellent written and verbal communication skills.
If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you.
Onsite position
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person workinggivesus the platform we need to connect, work atpaceand challenge perceptions.That’swhy we work, on average, a minimum of three days per week from the office. But that doesn’tmeanwe’renot flexible. We balance the expectation of being in the office whilerespecting individualflexibility. Join us in our unique and ambitious world.
Date Posted
09-Feb-2026Closing Date
08-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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