After sucessfully filling the recent vacancy for a Site Regulatory officer, Jenn Dinan at Wallace Myers is recruiting a 2nd REGULATORY SITE OFFICER to work on contract at our Global Biopharma client's site in Waterford.

Looking for someone coming from a more technical background this time. If you have any experience supporting manufacturing, validation or tech transfer this would be ideal

Contact Jenn Dinan on 014408352 or email

Job Title: Regulatory Site Officer (RSO)
Location: Waterford
Hybrid Working Available (up to 3 days remote)

Our Team:
The Regulatory Affairs Department in Waterford is responsible for managing products manufactured at the site from a regulatory perspective; ensuring submissions are on time, assessing change controls and deviations, and ensuring regulatory compliance.
Our team is energetic and close-knit, supporting one another where possible.

Main Responsibilities:

• Maintenance of, and variations to, CMC dossiers for assigned products.
• Provide technical regulatory support for manufacturing process changes, analytical methods, validation activities, and technology transfers.
• Review and assess Change Controls, CAPAs, validation documentation, and comparability assessments from a regulatory compliance perspective.
• Support and manage all regulatory requests impacting site products, including coordination of site expert responses to support GRA in responding to Requests for Information (RFIs) resulting from deficiency letters (DLs) from Health Authorities (HAs).
• Assess the regulatory impact of proposed site changes for assigned products.
• Review and approve Quality documentation, including batch records, specifications, plans, protocols/technical reports, SOPs, deviation assessments, and investigation reports, as appropriate.

Act as a second RSO reviewer for submission of documentation.

• Track all site regulatory activities in real time using planning tools.
• Monitor submission and approval status for assigned products.
• Participate in regulatory inspections and audits.
• Support initial BLA/MAA authoring and coordination where appropriate.
• Manage product registration renewals.
• Prepare annual reports (e.g. US, Canada, Brazil).
• Contribute to Periodic Quality Reviews (PQRs).
• Participate in project teams and provide regulatory guidance.
• Lead product-related and cross-functional meetings.
• Ensure alignment between site documentation and approved regulatory dossiers.

Compliance-Related Tasks:

• Regulatory/dossier compliance management.
• Creation and maintenance of Overarching and Batch-specific MARs/MCAs.
• Manage legalisation and notarization requests.
• Prepare and update Site Master File (SMF).
• Maintain site accreditations (e.g. IMP license, manufacturing license, GMP certification).
• Manage site registrations and renewals (e.g. Foreign Manufacturing Registration).
• Distribute regulatory approval notifications to site teams.
• Perform document review within Veeva Vault.
• Ensure timely completion of quality-related tasks.

Experience:
Ideally 2 years' experience supporting post-approval variations and lifecycle management activities.

Soft Skills:
Strong problem-solving, communication, critical thinking, and time management skills. Ability to interpret scientific data and assess regulatory impact.

Technical Skills:
Experience in Regulatory Affairs, Manufacturing, and/or Quality Operations. Familiarity with Health Authority interactions within a corporate structure is advantageous.

EDUCATION:

Degree in Science, Pharmacy, or related discipline (required).
Languages: English.

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

At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.

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