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

About this role

Responsibilities

• 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.