On behalf of our client, we are currently recruiting for a Regulatory Officer for a maternity contract cover. This role will be approx 11 months duration. The role will be hybrid within the Dublin 9 office.
Key responsibilities: To support the regulatory activities and the maintenance of the Quality Management System (QMS) in the Irish affiliate. The overall purpose of the role is to ensure product quality, regulatory compliance and patient safety with a focus on business-critical issues that may have an impact on license to operate and inspection readiness.
Regulatory:
· Support all regulatory affairs activities for medicinal products and medical devices on the Irish market
· Lead assigned regulatory projects, launches and initiatives for the Irish market
· Ensure compliance with regulations, laws and industry policies that affect company products
· Support the lifecycle management of product licenses, ensure submissions and approvals are timely and in line with HQ strategies
· Ensure high quality compliant labelling for all marketed products
· Work collaboratively with other affiliates regarding shared labelling and any other applicable shared regulatory activities
· Communicate planned changes to regulatory files and products to relevant stakeholders within the affiliate
· Review and update local regulatory SOPs
· Ensure timely updates of critical systems, e.g. Vault RIM, to ensure compliant product is released to the market
· Work collaboratively with the relevant Country, Regional and HQ teams to establish, prepare and implement regulatory strategies within agreed timescales
· Interface, collaborate and negotiate with external stakeholders such as relevant government agencies (e.g. HPRA, HSE) and industry associations (IPHA) to ensure continued compliance and to gain knowledge of new requirements that require local implementation
· Initiate and complete activities related to regulatory non-compliances, deviations and change requests
· Assist with local activities for stock shortages
Quality:
· Assist with ensuring that the QMS in the affiliate is maintained and in compliance with company requirements and external requirements
· Support, maintain and implement GxP activities as required
· Support training and communication of the QMS throughout the local affiliate organisation
· Interact cross functionally throughout the Irish affiliate to improve and maintain the QMS, by driving simplicity and robust processes
· Support simplification of quality to strengthen compliance and increase agility by driving improvements within the QMS
· Act as Quality Representative for Quality Issues in Ireland in Quality Lead’s absence
· Support archiving in Vault RIM of relevant quality documentation
· Act as reviewer/approver of IT processes
Requirements
· 3rd level qualification, preferably graduate in Life Sciences
· Pharmaceutical industry experience
· Experience in Regulatory Affairs
· Attention to Detail
· Regulatory and Quality Knowledge
· Critical Thinking and Problem Solving
· Communication Skills
· Collaboration and Teamwork
· Time Management and Prioritization
· Adaptability and Continuous Learning
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
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