Regulatory Submissions Specialist
hace 4 semanas
Overview Regulatory Submissions Specialist (with Portuguese) This role requires working on National Holidays and weekends as needed. Responsibilities Process safety data according to applicable regulations, guidelines, SOPs, and project requirements. Review, assess, and process safety data and information from various sources. Distribute reports/data to internal and external third parties following applicable regulations, SOPs, and internal guidelines under the guidance of senior operations team members. Track cases as applicable to the project plan. Identify and report quality problems to senior team members. Liaise with different functional team members and health care professionals to address project-related issues. Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes. Qualifications Bachelor\'s degree in life sciences (mandatory) Advanced level of English (mandatory) Advanced level of Portuguese (mandatory) 1-2 years of experience in pharmacovigilance activities; ideal profile includes regulatory submissions experience. Good knowledge of medical terminology and safety databases (ARGUS). Strong organizational skills, attention to detail, and ability to work independently and as part of a team. Work modality 100% home-based Will require to work some National Holidays Will require to work alternate weekends What we offer Private Medical Insurance Internet allowance Employee Assistance Program: free and confidential support available 24/7 for you and your family such as counselling, referrals and work-life resources Gympass Additional week of vacations 100% work from home IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. Learn more at #J-18808-Ljbffr
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Experienced Regulatory Affairs Specialist
hace 4 semanas
Municipio de Avellaneda, Argentina Johnson & Johnson Innovative Medicine A tiempo completoExperienced Regulatory Affairs Specialist Join us as an Experienced Regulatory Affairs Specialist based in Buenos Aires, Argentina or Santiago, Chile. You will be responsible for end‑to‑end regulatory lifecycle management of labeling updates across Argentina, Chile, Uruguay, Paraguay, and Bolivia. Purpose Execute the complete labeling lifecycle...
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Site Readiness and Regulatory Specialist I
hace 3 semanas
Municipio de Esquel, Argentina Fortrea A tiempo completoSite Readiness and Regulatory Specialist I Job Overview Primary contact with investigative sites during study maintenance and, when assigned, site startup activities, responsible for collecting required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the agreed timelines with...
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FSP - Regulatory & Start Up Specialist
hace 3 semanas
Municipio de Esquel, Argentina IQVIA A tiempo completoOverview The Regulatory and Start-Up Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Responsibilities...
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Senior Study Start-up
hace 2 días
Municipio de Rincón de los Sauces, Argentina Emmes Group A tiempo completoA leading clinical research organization is seeking a Study Start-up Associate Senior in Rincón de los Sauces, Argentina. This role is vital for coordinating regulatory submissions and ensuring compliance with local and global requirements in clinical trials. Ideal candidates will have over 6 years of experience in regulatory affairs across multiple...
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Lab Tech Specialist
hace 3 semanas
Municipio de Esquel, Argentina IQVIA A tiempo completoLab Tech Specialist – IQVIA Job Overview The Lab Technical Specialist performs procedures to monitor the performance and reporting of laboratory assays. Essential Functions Develops and maintains the local laboratory Quality Control Program and database, performs statistical analysis of data and quality control performance data reviews in accordance with...
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Sr. QARA Specialist
hace 2 semanas
Municipio de Rincón de los Sauces, Argentina Teleflex A tiempo completoSr. QARA Specialist (Technical Director) As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional...
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FSP - Regulatory & Start Up Specialist
hace 2 semanas
Ciudad Autónoma De Buenos Aires, Argentina IQVIA A tiempo completoThe R egulatory and Start-Up Specialist will Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions Under...
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Senior RA Specialist
hace 2 días
Municipio de Esquel, Argentina Merck Healthcare A tiempo completoSenior RA Specialist – Merck Healthcare Location: Buenos Aires, Buenos Aires Province, Argentina Responsibilities Monitorear diariamente las páginas web de ANMAT y todos los asuntos relevantes relacionados y competidores, incluyendo la difusión por correo electrónico ("Regulatory News"). Mantenerse actualizado y difundir legislaciones regulatorias....
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Senior CRA
hace 3 semanas
Municipio de Esquel, Argentina IQVIA A tiempo completoJoin or sign in to find your next job Join to apply for the Senior CRA role at IQVIA 1 month ago Be among the first 25 applicants Join to apply for the Senior CRA role at IQVIA The Senior Clinical Research Associate (CRA) will play a crucial role in the planning, execution, and management of clinical trials. This position requires a highly skilled and...
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Contract Negotiator
hace 6 días
Municipio de Esquel, Argentina IQVIA A tiempo completoContract Negotiator – IQVIA Location: Argentina – Full Home Based What You'll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. Act as Point of Contact...