Regulatory Affairs and Medical Information Specialist

Regulatory Affairs and Medical Information Specialist

Location: Dublin, Ireland

Competitive Salary and Benefits

Introduction to role

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. Provide medical information to external and internal customers upon receipt of queries and report product quality complaints in line with company SOPs.

Accountabilities

• 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 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/Experience

• Life Sciences Degree or appropriate professional qualifications.
• Minimum two years’ experience in a regulatory affairs or medical information role.
• 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
• Experience with CESP submissions and eCTD lifecycle maintenance activities

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 are an equal opportunity employer and

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 authorisation and employment eligibility verification requirements.