Jenn Dinan at Wallace Myers is recruiting a REGULATORY SITE OFFICER to work on contract at our Global Biopharma client's site in Waterford.

Contact Jenn Dinan on 014408352 or email

Job type: PAYE Temp contract - Salary 48k pro rate per annum

Contract Duration: 9 Months

Pre-requisite: Must be already eligible to work in Ireland . Valid work permit or EU passport required to apply

Regulatory Site Officer (RSO)

Our Team:

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 because 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 to 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

Compliance 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.
• Document review (Veeva Vault).
• Ensure Quality tasks are completed in timely manner.

About you

• Education: Degree in Science, Pharmacy or related discipline is essential.
• Experience: preferably 2 years
• Soft 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.
• Languages: English.

All applications will be treated with the strictest of confidence - contact Jenn Dinan on 014408352 or email

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