Regulatory Affairs and Medical Information Specialist 12 Month FTC

Regulatory Affairs and Medical Information Specialist 12 month FTC Location: Dublin, Ireland Competitive Salary and Benefits Introduction to role You will provide medical information to external and internal customers upon receipt of queries and report product quality complaints in line with company SOPs. Deliver 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. Accountabilities Work in close collaboration with other Medical Information colleagues on the provision of a comprehensive medical information service to internal and external customers in line with company and industry standards. Respond to more complex queries on pharmaceutical products from internal and external stakeholders, escalated by third party vendor. Identify opportunities to improve processes within Medical Information and provide practical solutions within area of expertise. Develop standard responses for use as considered appropriate. Update job aids and liaise with third party vendor to ensure understanding. Support with the creation, review and update of key local procedural documents. Assist Medical Information colleagues in covering annual leave or other business absences. Ensuring that all activities are conducted in an ethical, responsible, and lawful manner as set out in the AZ Global Policies & Standards and complying with the IPHA Code and Legislation. Ensure 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 timely quality issue reporting, assessment, and CAPA creation and implementation as necessary. Essential Skills/Experience Life Sciences Degree or appropriate professional qualifications. Minimum two years’ experience in medical information role and/or Regulatory Affairs Good written and verbal communication skills Excellent attention to detail. Ability to make optimal use of IT systems. Customer focus. Desirable Skills/Experience Post-graduate qualification Experience of working on cross-functional teams Knowledge of the drug development process Product/therapy area knowledge for AZ brands/products Certification and/or familiarity with IPHA Code At 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 will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Date Posted 18-Dec-2025 Closing Date 10-Jan-2026 Our 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.