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 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 treatmentsofOncologicaldiseases!

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 functionwerefocused and committed to the development of our products as well as to our people. We provide an open and supportive space to explorelearnand 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 theOncology Regulatory Science Strategy and Excellence (ORSSE)in the roleasRegulatory Affairs Associate (RAA).

Whatyoulldo

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 teamis 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)
• Planningpreparingand executing simple submissions andassistingwith the preparation and planning of regulatory dispatches.
• Be the interface with Health Authority (HA) and its systems for designated regulatory of user fees receipt of incoming FDA correspondence use of HA Portalssuch as CTIS.
• Responsible for the ordering and tracking of specific regulatory requirements such as registration samples Legal ofAuthorisation Powers of Attorney Translations of regulatory documentation
• Provide support across the group for assigned non-drug project roles & 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 scienceadministrationor 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

Closing Date

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.