Regulatory Affairs Specialist, Waterford

Our client who is a leading pharmaceutical company is looking for a Regulatory Affairs Specialist for a 9-month contract. If you have experience in regulatory affairs in the pharmaceutical or biopharmaceutical industry then this is the job for you!! This is a hybrid position with 3 days on site and 2 days working from home

The Role

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.

Periodic Quality Reviews (PQR).

Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites.

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).

Requirements

Degree in Science, Pharmacy or related discipline is essential.

Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable.

2-5 years experience within the pharmaceutical or biopharmaceutical background.

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