Quality and Regulatory Specialist

Quality and Regulatory SpecialistSkip to main contentWe use cookies and tracking technologies to offer you a better browsing experience, analyze site traffic, and improve the website.# AmerisourceBergen is now Cencora! Explore our careers.Quality and Regulatory Specialist page is loaded Quality and Regulatory SpecialistApplylocations: Cork, Irelandtime type: Full timeposted on: Posted Todaytime left to apply: End Date: July 13, 2026 (12 days left to apply)job requisition id: ROur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# Job Details About the Role This role is in support of BluePoint Laboratories, a Cencora business offering a trusted source of generic pharmaceuticals.This is a fantastic opportunity in a role that blends hands-on Quality Assurance with Regulatory Affairs, giving you the chance to grow across both disciplines at the same time. The product portfolio is constantly evolving, from pharmaceuticals and medical devices to exciting emerging areas like biosimilars, so there is always something new to get involved in.As a virtual operation, you will collaborate with colleagues across multiple countries, bringing real international exposure to your day-to-day work. A structured training plan is in place to set you up for success from day one. Location : Little Island, Cork Shift Pattern : 39 hours per week, Monday to Friday Working Model : Hybrid, 2 to 3 days on-site, with the remainder from home Key Responsibilities Ensure ongoing compliance with cGMP, Environmental, Health and Safety regulations Execute all Quality Management System activities including non-conformances, deviations, change control, complaints, CAPA, document control and record retention Manage and execute the finished product non-conformance process and support timely product release Lead regulatory updates to product labelling, ensuring compliant and timely product launches Create and maintain National Drug Codes (NDC), Universal Product Codes (UPC) and Structured Product Labelling (SPL) for FDA submissions Ensure company and product registration is maintained in all appropriate markets and with relevant regulatory agencies Review and approve product labelling, patient package inserts and associated documentation Develop, implement and maintain Standard Operating Procedures (SOPs) Monitor Key Performance Indicators (KPIs) to track performance and identify opportunities for improvement Stay current with evolving regulatory trends and requirements Promote and maintain a safe, healthy working environment. Skills and Experience Essential: Minimum BSc in a scientific discipline (e.g. Chemistry, Biology or related field) At least 5 years' experience in a Quality Assurance role within a cGMP environment Experience with CAPAs, deviations, change control and other core QMS processes Strong background in the pharmaceutical industry, ideally within a manufacturing setting Excellent written and verbal communication skills with strong attention to detail Proven ability to work both independently and collaboratively across cross-functional teams Strong problem-solving and critical thinking skills Proficient in Microsoft Office (Excel, Word) and Document Management Systems Desirable: Experience in Regulatory Affairs, particularly around labelling and submissions Familiarity with Medical Device regulations Experience with Artwork review and/or Supplier Quality What's on Offer Competitive salary Annual performance bonus Private healthcare coverage Company pension scheme A genuinely varied role combining Quality Assurance and Regulatory Affairs in one position International exposure through a virtual, cross-country working environment Structured onboarding and training plan to support your success from day one Opportunities to work on exciting new product areas, including biosimilars# What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.Full time