Regulatory Submission Specialist
hace 1 semana
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 authorities Manages 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 submission ICF customization; Contracts and budget negotiation, CTIS (The Clinical Trials Information System) experience - a new central way how EU submission are being processed Minimum 2 years' experience in a pharmaceutical or Clinical Research Organization Good knowledge of ICH / GCP regulations / IRB Fluent in English Good planning, problem solving and organizational skills What 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. Candidate Privacy Policy
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Regulatory submission specialist
hace 2 semanas
Madrid, España OPIS A tiempo completoDue 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....
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Regulatory submission specialist
hace 2 semanas
Madrid, España OPIS A tiempo completoDue 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.¿Todo listo para enviar su solicitud? Asegúrese de comprender todas las responsabilidades y tareas asociadas a este puesto antes de continuar.We are looking for someone who can...
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Regulatory Submission Specialist
hace 2 semanas
Madrid, Madrid, España OPIS A tiempo completoDue 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...
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Regulatory submission specialist
hace 6 días
Madrid, España OPIS A tiempo completoDue to our ongoing global expansion, we have a great opportunity for a¿Es usted el candidato adecuado para esta oportunidad? Asegúrese de leer la descripción completa 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...
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Remote Regulatory Submissions Specialist
hace 3 días
Madrid, España OPIS A tiempo completoA global CRO is looking for a Regulatory Submissions Specialist to join their regulatory team remotely. The ideal candidate will manage regulatory submission activities, ensuring compliance with global and local requirements. The role demands fluency in English and strong planning and organizational skills. Experience in contract negotiation and procedural...
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Regulatory Affairs Specialist
hace 2 semanas
Madrid, España Indero A tiempo completoOverview Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and / or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and...
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Regulatory Affairs Specialist
hace 2 semanas
Madrid, España Indero A tiempo completoOverviewInscríbase rápido, consulte la descripción completa desplazándose hacia abajo para conocer todos los requisitos de este puesto.Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and / or part II following EU CTR and other...
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Regulatory Affairs Specialist
hace 7 días
Madrid, España Indero A tiempo completoOverview Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and / or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and...
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Senior Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Indero (formerly Innovaderm) A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
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Senior Regulatory Affairs Specialist
hace 2 semanas
Madrid, España Indero A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
