Regulatory Affairs and Medical Information Specialist15 Month FTCLocation: Dublin, IrelandCompetitive Salary and BenefitsIntroduction to roleDeliver and maintain competitive licences for Ireland/Malta, ensuring regulatory compliance for defined product and project responsibilities. You will be responsible for the preparation, submission, and management of all submissions within the remit of product responsibility. Ensure compliance with requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and standards. Provide medical information to external and internal customers upon receipt of queries and report product quality complaints in line with company SOPs.AccountabilitiesEnsure timely submission and approvals of all regulatory applications and compliance with Ireland/Malta regulatory requirements.Adhere to appropriate standards and policies for all aspects of the company’s regulatory activities.Archive regulatory documentation.Maintain and update internal databases to satisfy audit or inspection requirements.Provide regulatory input to stock and supply issues, monitoring stock and informing regulatory agencies about potential and actual shortages.Liaise with Operations to manage pack changes and ensure labelling compliance.Prepare and maintain product information for all registered licences in Ireland/Malta. Manage and review product information published on external websites to ensure accuracy.Circulate regulatory updates, including updated product information, to relevant stakeholders.Participate as a member of cross-functional delivery teams, providing regulatory advice on issues.Support the GRP lead to ensure full compliance with GRP requirements in line with local QMS procedural documents.Support the implementation of new global systems and processes within the team.Assist with the creation, review, and update of key local procedural documents.Support timely quality issue reporting, assessment, and CAPA creation and implementation as necessary.Essential Skills/ExperienceLife Sciences Degree or appropriate professional qualifications.Minimum two years’ experience in a regulatory affairs or medical information role.Good written and verbal communication skillsExcellent attention to detail.Ability to make optimal use of IT systems.Customer focus.Desirable Skills/ExperiencePost-graduate qualificationExperience of working on cross-functional teamsKnowledge of the drug development processProduct/therapy area knowledge for AZ brands/productsCertification and/or familiarity with IPHA CodeExperience with CESP submissions and eCTD lifecycle maintenance activitiesAt AstraZeneca, we are at the forefront of pioneering new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. We lead from the front, ensuring everyone's voice is heard, building trust and respect within our teams. Adaptable and agile, we draw on the diverse expertise of our teams to overcome obstacles. Our supportive environment encourages cross-functional collaboration, driving us to deliver better outcomes for our patients every day!Ready to make a difference? Apply now to join our team!We are an equal opportunity employer andDate Posted27-Mar-2025Closing Date05-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.