Regulatory Site Officer

Role overview

Tandem Project Management Ltd. is hiring a Regulatory Site Officer for a biopharmaceutical site in Waterford. The role supports the team that manages products made on site from a regulatory standpoint, with responsibility for keeping submissions on schedule, reviewing change controls and deviations, and helping maintain regulatory compliance.

Key responsibilities

• Maintain the CMC dossier for the products assigned to the site, including updates and variations.
• Coordinate and support regulatory requests that affect site products, including gathering input from site experts to help Global Regulatory Affairs respond to requests for information linked to deficiency letters from health authorities.
• Evaluate the regulatory effect of proposed site changes for assigned products.
• Review and approve quality documents as appropriate, including batch records, specifications, plans, protocols, technical reports, SOPs, deviation assessments, and failure investigations.
• Provide a second review of submission documentation.
• Keep all site regulatory activities updated in real time within planning and tracking tools.
• Monitor submission and approval progress for assigned products and record status changes.
• Take part in regulatory audits and inspections.
• Support initial authoring and coordination of BLA/MAA submissions where needed.
• Handle product registration renewals.
• Prepare annual reports, including those for the US, Canada, and Brazil.
• Support periodic quality reviews (PQRs).
• Contribute to project teams and provide regulatory direction and support.
• Own product-related meetings, including core site meetings and discussions with GRA/RSO colleagues at sister sites.
• Support regulatory and dossier compliance activities.
• Create and maintain overarching and batch-specific MARs/MCAs.
• Manage legalisation and notarisation requests.
• Prepare and maintain the Site Master File.
• Support local site accreditations such as investigational manufacturing licence, manufacturing licence, and GMP certification.
• Handle site registrations and renewals, including foreign manufacturing registrations.
• Distribute approval notifications to the site.
• Review documents in Veeva Vault.
• Ensure quality tasks are completed within required timelines.

Qualifications and experience

A degree in Science, Pharmacy, or a closely related field is required. The role needs at least 2 years of relevant experience. Background in Regulatory Affairs, Manufacturing, or Quality Operations, especially with Health Authorities and working within a corporate structure, is considered an advantage.

Additional information

This is an onsite contract role based in the Waterford Metropolitan Area.