Regulatory Site Officer

Role Summary:

• Our client, a biopharmaceutical company based in Co. Waterford, is seeking a Regulatory Site Officer to join their Regulatory Affairs Department, 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.
• The team is an energetic and close-knit, helping each other where we can.

Core Duties and 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

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.

Minimum Qualifications and Experience:

• Education: Degree in Science, Pharmacy or related discipline is essential.
• Experience: preferably 2 years+ in a similar role
• 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.