Job Description
On behalf of my client, a global pharmaceutical company, we have a new opportunity for a Senior Regulatory Affairs Officer to join the Dublin team. Hybrid opportunity.The Role:Provide regulatory affairs support and manage International MAAs and Lifecycle activities for their current and actively growing range of pharmaceutical products, CAMs, and our R&D pipeline products’ therapeutic indications and international markets. Promote and facilitate team and corporate growth and success.Key Responsibilities:Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, and ad hoc R&D pipeline).Preparation and filing of submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing.Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.Support the strategic and operational planning and registration of CAMs in global markets.Actively participates and employs effective communication practices with internal customers (CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).The Person:Life science related degree + 5 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).Positive and pro-active approach and attitude to business tasks.Ability to lead and support several concurrent projects/products and develop strong relationships within cross-functional teams.Experience of emerging markets / international RoW markets and regulatory filings.Quality control review of technical/regulatory documents.Understanding of Regulatory strategy and determination of documentation requirements.Compliance with SOPs, Change controls and regulatory best practices.For full job spec and details, email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com#LI-TD1 #J-18808-Ljbffr