Our client, a biopharmaceutical company based in Co. Waterford, is seeking a Regulatory Site Officer to join their Regulatory Affairs Department, responsible for managing products manufactured at Waterford from a regulatory perspective; ensuring submissions are submitted on time, assessing change controls and deviations and ensuring regulatory compliance.The team is an energetic and close-knit, helping each other where we can.Core Duties and Responsibilities:Maintenance of, and variations to, CMC Dossier for assigned products.Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs).Assess the regulatory impact of proposed changes by site for assigned products.Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/ technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate.Second RSO review for submission documentation.Track all site regulatory activities in real time within the site planning tracking tools.Monitor submission/approval status and track updates for assigned products.Participate in regulatory inspections/audits.Initial BLA/MAA authoring/coordination, as appropriate.Product Registration Renewals.Periodic Quality Reviews (PQR).Contribute in project teams and provide regulatory guidance/ support.Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sitesCompliance Related Tasks:Regulatory or Dossier Compliance.Creation and maintenance of Overarching and Batch specific MARs/MCAs. Legalisations and notarisation requests.Preparation of Site Master File (SMF).Maintenance of local site accreditations e.g. investigational manufacturing license (IMP), manufacturing license and GMP certification.Site Registrations & Renewals e.g. Foreign Manufacturing Registration (FMR).Distribution of approval notification to site.Ensure Quality tasks are completed in timely manner.Minimum Qualifications and Experience:Education: Degree in Science, Pharmacy or related discipline is essential.Experience: preferably 2 years+ in a similar roleSoft skills: Problem Solving, effective communication, critical thinking and time management.Technical skills: Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable.
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