Job description
The Regulatory Affairs Department in Waterford is responsible for managing products manufactured at Waterford from a regulatory perspective; ensuring submissions are submitted ontime, assessing change controls and deviations and ensuring regulatory compliance.
Our team is an energetic and close-knit, helping each other where we can.
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 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.
About you:
* Experience: preferably 2 years+
* Soft skills: Problem Solving, effective communication, critical thinking and time management.
* Technical skills: Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Heal Authorities and working through corporate structure is desirable.
* Education: Degree in Science, Pharmacy or related discipline is essential.
* Languages: English.
Please send your CV to [email protected]
