Regulatory Affairs Manager (5 Yrs Exp)
Our client are a Global start-up speciality pharmaceutical company (a subsidiary funded by a multi-billion US global biopharmaceutical company). Due to growth, this organisation requires a Regulatory Affairs Manager to join the team in Dublin on a permanent basis. The Role. Reporting into the Head of Regulatory Affairs and Pharmacovigilance, as RA Manager you will be responsible for the following: Regulatory maintenance of EU (MAs) and US NDAs. Maintenance will include items such as generation and submission of Type I and II variations applications in EU and FDA filings. Updating CTD registrations. Providing Regulatory Affairs support on Change Controls within the company approval system. Generation and management of prescribing information, patient information leaflets and packaging components, including artwork management, that are in line with regulatory requirements and company approval systems. Participate in technology transfers, validation activities with CMOs, external vendors and internal cross functional teams including Manufacturing & Logistics and Quality departments. Supporting corporate acquisitions as needed within a growing biopharma company. Provide regulatory support product launches and out-licensing activities in global markets. Maintaining a sound knowledge of EU and US regulatory requirements, regulations and guidelines to provide advice internally for matters related to products. The Person. In order to be considered you must have the following: 6-8 years practical/hands-on EU and US experience of working in a pharmaceutical regulatory affairs role in the pharmaceutical industry. Qualifications: Degree or advances degree in a life-science subject or pharmacy. Excellent technical, verbal and written skills. Self-starter who will work with minimal supervision. Eligible to work in EU. To discover more about this opportunity, apply online or contact Gillian McMurrough at HRM on 353 1 6321827 for a confidential discussion. This job originally appeared on RecruitIreland.com.
Dublin City Centre, Dublin
8 days ago