University of Coimbra (Portugal) opens a call for a PhD-holding position as Project Manager & Regulatory Affairs Officer of the project Capacity 2023, Consortium for Developing Regulatory Capacity for Clinical Trials using Gene Therapy products and Strengthening Pharmacovigilance in the Conduct of Clinical Trials in East Africa (reference: 101145599), funded by the European Union through Horizon Europe HORIZON-JU-GH-EDCTP3-2023-01-05, in the following conditions:Scientific area: Regulatory affairsSkills/Qualifications: A PhD in a research field relevant for the development of the above delineated work plan and proficiency in Regulatory affairs. Preference will be given to applicants with proven experience in Regulatory affairs in the areas of Health sciences, biomedicine or health biotechnology. Fluency in both English and Portuguese (C1 level of the Common European Framework of Reference for Languages (CEFR)). Demonstrated ability to develop Regulatory affairs frameworks. Experience in medicinal products development and GMP certification of gene and/or cell therapy products by regulatory agencies. Strong written and verbal communication skills, ability to work independently and as part of a team, excellent organizational and time-management skills.Work plan/Objectives: The Capacity 2023 aims to develop frameworks for clinical trial oversight for gene therapy products, to strengthen the capacity of regulatory agencies for oversight of clinical research using gene therapy products, to build capacity of researchers and clinicians in the use of gene therapies and to strengthen Pharmacovigilance systems in the conduct of Clinical Trials. Thus the Project Manager and Regulatory Affairs Officer will play a pivotal role in helping to establish and promote this project, monitoring the development of the main objectives of the Capacity 2023 among the project partners.Responsibilities: The Regulatory Affairs Officer will be in charge of: development, correction and supervision of gene therapy regulatory affairs documentation within the scope of the Capacity project, contact with regulatory agencies in the various countries of the partners involved in the project, support for project coordination in all regulatory affairs topics, development, implementation and execution of training within the scope of regulatory affairs, dissemination of the relevance of this topic in biomedical research and to the general public.Benefits: The successful candidate will be hired by the University of Coimbra under a full-time work contract of the duration of the project. According to the Portuguese legislation on public hiring of researchers (Decree-Law 124/99) the contract includes the payment of: Salary (monthly salary plus holidays and Christmas allowance); Basic social security coverage; Food allowance. For a work contract on a full-time basis, the annual gross salary offered is no less than 31,500.00 EUR.Location: Center for Neurociences and Cell Biology (CNC-UC), Rua Larga, 3004-504 Coimbra – University of CoimbraScientific leadership: Professor Luís Pereira de AlmeidaSend your application to: ****** information here: https://www.euraxess.pt/jobs/267408
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