Regulatory Site Officer (RSO)...

Regulatory Site Officer (RSO)

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• Location Waterford
  
• 23-month FTC
  
  About 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).
  
• Ensure Quality tasks are completed in timely manner.
  
  About you:
  
  
• 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.
  
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