Regulatory Site Officer

About the role

Our client, a biopharmaceutical company in County Waterford, is looking for a Regulatory Site Officer to join the Regulatory Affairs Department. The role will manage regulatory aspects of products manufactured at the Waterford site, ensuring timely submissions, overseeing change controls, deviations and maintaining compliance with health authorities.

Key responsibilities

• Maintain and update CMC dossiers for assigned products, including variations.
• Coordinate and support regulatory requests, responding to health authority deficiency letters and RFI activities.
• Assess regulatory impact of proposed site changes and review quality documentation such as batch records, specifications, SOPs, protocols and deviation assessments.
• Conduct second‑review of submission documentation and track site regulatory activities using planning tools.
• Monitor submission and approval status, participate in inspections/audits, and author/coordinate initial BLA/MAA submissions.
• Manage product registration renewals, annual reports (US, Canada, Brazil) and periodic quality reviews.
• Prepare and maintain Site Master File, local accreditations (IMP, manufacturing licence, GMP), and foreign manufacturing registrations.
• Create and maintain overarching and batch‑specific MARs/MCAs, handle legalisations and notarisation requests.
• Review documents in Veeva Vault and ensure timely completion of quality tasks.

Required profile

• Degree in Science, Pharmacy or a related discipline.
• At least 2 years of experience in a regulatory affairs, manufacturing or quality operations role.
• Strong problem‑solving, communication, critical‑thinking and time‑management abilities.

Required skills

• Regulatory affairs expertise.
• Manufacturing operations knowledge.
• Quality operations experience.
• Proficiency with Veeva Vault document management.