Regulatory Submission Specialist
hace 10 horas
Due to our ongoing global expansion, we have a great opportunity for a Regulatory Submissions Specialist to join our growing regulatory team in Taiwan, on a fully remote basis.We are looking for someone who can autonomously carry on the work within the scope of their activities and interacts with the Direct Manager to define priorities and manages workload. The Regulatory Submissions Specialist contributes to the management and development of procedures related to the activities in which he/she is involved in and ensures that the outputs of their activities meet the quality standards required by the company. Ensures the timely compilation of activity tracking and attendance systems.What you'll do:Develops and maintains knowledge of global and local regulatory requirements and industry practice/guidelines for submission activities.Manages adaptation of master documentation for submission (Informed Consent and any additional patient items such as patient emergency card, patient diary and questionnaires etc…) to local requirements.Manages activities associated with obtaining initial and amended central authority approvals from Competent Authorities (CAs), Central Ethics Committee (CECs), IRB and any other authoritiesManages contract and budget negotiation/execution with sites/investigators/other parties involved as applicable.Prepares the financial agreement/addendum to the financial agreement/loan/assignment letter for an external structure and obtain the Sponsor/OPIS signatures for the shipment to the Site.Maintains tracking of regulatory, ethics and administrative submission and approval dates.What we are looking for:Experience with CA and CEC submission, using combined ways of submissionICF customization;Contracts and budget negotiation,CTIS (The Clinical Trials Information System) experience - a new central way how EU submission are being processedMinimum 2 years’ experience in a pharmaceutical or Clinical Research OrganizationGood knowledge of ICH / GCP regulations / IRBFluent in EnglishGood planning, problem solving and organizational skillsWhat we offer:We offer a competitive salary, bonuses, and other benefits together with the opportunity to develop your professional career with an expanding and growing international company.Please read the information notice on the processing of personal data in the candidates’ information section of our company website.Who we are:OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.
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Regulatory Submission Specialist
hace 6 días
Castro, España OPIS A tiempo completoDue to our ongoing global expansion, we have a great opportunity for aDescubra si esta oportunidad es adecuada para usted leyendo toda la información que sigue a continuación.Regulatory Submissions Specialistto join our growing regulatory team in Taiwan, on a fully remote basis.We are looking for someone who can autonomously carry on the work within the...
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Senior Manager, Regulatory Labelling
hace 2 semanas
Castro, España Cpl Life Sciences A tiempo completoJob Title: Senior Manager, Regulatory Labelling ¿Interesado en saber más sobre este trabajo? Desplácese hacia abajo y descubra qué habilidades, experiencia y cualificaciones académicas se necesitan. Location: Spain, -Fully Remote Salary: Competitive Salary + Excellent Benefits Employee Type: Permanent As a Senior Manager, Regulatory Labelling you will...
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Senior Manager, Regulatory Labelling
hace 2 semanas
O Castro, España Cpl Life Sciences A tiempo completoJob Title: Senior Manager, Regulatory Labelling ¿Interesado en saber más sobre este trabajo? Desplácese hacia abajo y descubra qué habilidades, experiencia y cualificaciones académicas se necesitan. Location: Spain, -Fully Remote Salary: Competitive Salary + Excellent Benefits Employee Type: Permanent As a Senior Manager, Regulatory Labelling you will...
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Castro, España Kapadi A tiempo completoKapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and...
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Tax Compliance Specialist
hace 2 semanas
O Castro, España CSC A tiempo completoTitle: Senior Tax Compliance SpecialistSolicitar este puesto es sencillo. Desplácese hacia abajo y haga clic en "Solicitar" para ser considerado para esta posición.Schedule: Monday–Friday, 40 hours, hybridContract: Permanent, full timeSpanish and EnglishWe are looking for a Senior Tax Compliance Specialist to join our Tax team in Madrid (hybrid). In this...
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Pharmacovigilance Specialist
hace 7 días
Castro e Marzán, España ASPHALION A tiempo completo¡Be part of the future of drug safety at Asphalion! We're looking for a Pharmacovigilance Specialist ready to embrace new challenges in a fast-moving, international environment. If you thrive on precision and want to make a real impact, we'd love to have you on our team!Main responsibilities:Perform weekly global/local literature assessments.Efficiently...
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Digital Forensic Analyst
hace 10 horas
Castro, España Coforge A tiempo completoDigital Forensics SpecialistLocation: Spain, Portugal or Poland | Experience: 5+ years | Employment Type: Permanent / ContractAre you passionate about uncovering digital evidence and supporting high-stakes investigations? Join our team as a Digital Forensics Specialist , where you’ll play a critical role in safeguarding our organization by acquiring,...
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Pharmacovigilance Specialist
hace 4 semanas
Castro e Marzán, España ASPHALION A tiempo completo¡Be part of the future of drug safety at Asphalion! We’re looking for a Pharmacovigilance Specialist ready to embrace new challenges in a fast-moving, international environment. If you thrive on precision and want to make a real impact, we’d love to have you on our team!Main responsibilities:Perform weekly global/local literature assessments.Efficiently...
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Senior Tax Compliance Specialist
hace 2 semanas
O Castro, España CSC A tiempo completoTitle: Senior Tax Compliance Specialist La descripción completa del puesto cubre todas las habilidades asociadas, la experiencia previa y cualquier cualificación que se espera que tengan los solicitantes. Location: Madrid, Spain Schedule: Monday–Friday, 40 hours, hybrid Contract: Permanent, full time Languages: Spanish and English We are looking for a...
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IT & Cyber Risk Specialist
hace 2 semanas
Castro, España ING España & Portugal A tiempo completoAt ING we are looking for an IT & Cyber Risk Specialist¿Listo para inscribirse? Antes de hacerlo, asegúrese de leer todos los detalles pertenecientes a este trabajo en la descripción a continuación.Your role and work environment:We are looking for a talented and enthusiasticIT & Cyber Risk Specialistto join ourIT & Cyber Risk AreaTeam ofCISOThe...
