Regulatory Site Officer (RSO)
3 days ago
Hertford
Regulatory Site Officer (RSO) Have you got what it takes to succeed The following information should be read carefully by all candidates. • Location Waterford For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing. About the job The Regulatory Affairs Department in Waterford is 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. Our team is an energetic and close-knit, helping each other where we can. Main 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., • Annual Reports e.g. US, Canada, Brazil., • 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 sites., • 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., • Document review (Geode+/Veeva Vault)., • Preferably 2 years+ in a similar role., • Problem Solving, effective communication, critical thinking and time management., • Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Heal Authorities and working through corporate structure is desirable., • Degree in Science, Pharmacy or related discipline is essential.null