Regulatory Site Officer (RSO)...

Sanofi EU
Hertford
6 months ago
Applications closed

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Regulatory Site Officer (RSO)

Have you got what it takes to succeed The following information should be read carefully by all candidates.

  • 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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