Posted:
2/8/2026, 7:40:10 PM
Location(s):
Masovian Voivodeship, Poland ⋅ Warsaw, Masovian Voivodeship, Poland
Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior
Field(s):
Legal & Compliance
Workplace Type:
Hybrid
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 within regulatory affairs? Do you want to be part of a cross functional and global team, applying your administrative skills in a science focused environment and grow your expertise within Regulatory Affairs Management? Then join us to discover future treatments of Cardiovascular, Renal and Metabolic (CVRM) 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 looking for a new members to join our Regulatory Affairs Management team within the CVRM therapeutic areas, in the roles as Regulatory Affairs Associate (RAA).
What you’ll do
The Regulatory Affairs Associate assists other members of Regulatory Affairs Management group in obtaining and maintaining licenses and applications in accordance with agreed 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 CVRM organisation and is accountable for end to end delivery of regulatory submissions in line with business priorities by providing regulatory expertise, efficient project management and strong leadership.
Your main accountabilities/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, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
Provide support across the group for assigned non-drug project roles & responsibilities e.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 this role?
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
Proficiency with 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, administration or 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.
Website: https://www.astrazeneca.com/
Headquarter Location: Bangalore, Karnataka, India
Employee Count: 1001-5000
Year Founded: 1999
IPO Status: Public
Industries: Emergency Medicine ⋅ Manufacturing ⋅ Medical ⋅ Oncology ⋅ Pharmaceutical