Regulatory Affairs Associate - Oncology Regulatory Science, Strategy and Excellence (12 months fixed-term)

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 Oncological 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 Oncology Regulatory Science, Strategy and Excellence (ORSSE)  in the role 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 team 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, use of HA Portals such as CTIS. 
• 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

28-kwi-2026

Closing Date

04-maj-2026

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 authorization and employment eligibility verification requirements.