Purpose
The Regulatory Affairs Department 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.
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.
Qualifications/Experience
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 Health Authorities and working through corporate structure is desirable.
Education: Degree in Science, Pharmacy or related discipline is essential.
Languages: English.
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