Up to €48 000 per annum paid holidays, subsidized canteen.
Contact: Jenn Dinan, 01440 8352
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.
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.
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.
Ensure Quality tasks are completed in a 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 in Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable.
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