Regulatory Submission Specialist
il y a 4 semaines
For one of our clients, a global health care company, we are looking for an experienced Regulatory Submission Specialist. Job Description The Submission Specialist supports regulatory activities at study start up, focusing on submission to Ethics Committees (EC) and Competent Authorities (CA). ResponsibilitiesPrepare documents for Ethics Committee/Competent Authority (EC/CA) submission.Initiate translation of documents as applicable; review and adapt translations as appropriate.Prepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable.Interpret clinical study protocols in order to support EC/CA submissionAct as the point of contact for EC /CASupport approval processSupport budget adoption to country and site requirements.Prepare submission to any other authority when applicable.Maintain local regulatory documents on paper or electronically as applicable and ensure upload to appropriate system.Assist with collection of site essential documents.Attend project related meetings.Comply with all regulations in force, Company policies, operating procedures, processes, and task assignments.Inform manager if timelines appear to be at risk so that appropriate actions may be taken.Serves as a liaison to clinical teams and site personnel for administrative questionsRequirementsBachelor's or Master's degree, previous experience with EC/CA submissions Fluent in English, any other language is an assetAbility to use discretion and handle sensitive/confidential information.Ability to work independently when necessary.Ability to exchange straightforward information, ask questions, and check for understanding.Ability to multitask, prioritize and meet deadlines.Contract InformationFull-time positionOffice-based position in a dynamic, international environmentPermanent contractJOb number : 26637
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Regulatory Submission Specialist
il y a 3 semaines
Brussels, Belgique Oxford Global Resources Temps pleinFor one of our clients, a global health care company, we are looking for an experienced Regulatory Submission Specialist.Job DescriptionThe Submission Specialist supports regulatory activities at study start up, focusing on submission to Ethics Committees (EC) and Competent Authorities (CA).Responsibilities Prepare documents for Ethics Committee/Competent...
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Regulatory Affairs Associate, Bnl
il y a 3 jours
Brussels, Belgique Reckitt Temps pleinWorking in partnership with Global Regulatory, and under the responsibility of the RA manager Personal Care FR and BNL, You will be a key point of contact to Global Regulatory and local Regulatory teams with respect to cosmetic, detergent and biocides regulation, relaying knowledge about external factors and internal impact on processes and timings. You...
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Senior Chemical Regulatory Consultant
il y a 1 jour
Brussels, Belgique Pro5.ai Temps pleinClient BackgroundOur client is a global regulatory consulting provider supporting organizations with chemical safety, compliance strategies, and regulatory submissions across international markets. Their team works closely with clients to interpret evolving EU chemical regulations and ensure products meet all required compliance standards. They are expanding...
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PMCF Specialist
il y a 4 semaines
Brussels, Belgique Panda International Temps pleinPMCF Specialist (Medical Devices / Clinical & Regulatory Affairs)Start Date: ASAPContract Duration: 12 months (possibility of extension)Location: Diegem, BelgiumJob DescriptionAs a PMCF Specialist, you will join the Clinical and Regulatory Affairs team at a leading global healthcare company’s Medical Devices division in Diegem, Belgium.In this role, you...
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PMCF Specialist
il y a 3 semaines
Brussels, Belgique Panda International Temps pleinPMCF Specialist (Medical Devices / Clinical & Regulatory Affairs)Start Date: ASAPContract Duration: 12 months (possibility of extension)Location: Diegem, BelgiumJob DescriptionAs a PMCF Specialist, you will join the Clinical and Regulatory Affairs team at a leading global healthcare company's Medical Devices division in Diegem, Belgium.In this role, you will...
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PMCF Specialist
il y a 4 semaines
Brussels, Belgique Panda International Temps pleinPMCF Specialist (Medical Devices / Clinical & Regulatory Affairs)Diegem, Belgium – 12-Month Contract (Extension Possible)Job DescriptionAs a PMCF Specialist, you will join the Clinical and Regulatory Affairs team at a leading global healthcare company's Medical Devices division in Diegem, Belgium.In this role, you will play a key part in ensuring ongoing...
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Non Clinical Statistician
il y a 4 semaines
Brussels, Belgique Planet Pharma Temps pleinCMC Statistician (Contractor) – Biopharma SectorWe're seeking a CMC Statistician to provide expert statistical consultancy in the context of biological and gene therapy molecules. This role is ideal for someone passionate about applying advanced statistical methods to support CMC development, process optimization, and regulatory submissions in a dynamic...
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Senior Principal Medical Writer
il y a 4 semaines
Brussels, Belgique WhatJobs Temps pleinSenior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Join to apply for the Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor role at Syneos Health Description Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...
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Senior Clinical Research Associate
il y a 1 jour
Brussels, Belgique Planet Pharma Temps pleinPlanet Pharma are currently partnered with a global clinical research organisation and we are actively seeking a Senior CRA to join the business on a permanent basis, fully remotely in Belgium.Key Responsibilities:Monitor clinical trial sites to ensure studies are conducted according to protocol, Good Clinical Practice (GCP), and regulatory...
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Risk Specialist
il y a 3 jours
Brussels, Belgique Wise(formerly Transferwise) Temps plein**Office**: Brussels **Team**: Compliance **Salary Range**: 4200 - 5300 EUR per month + RSUs Since 2011, Wise has had a clear mission: money without borders. Built by and for people who live global lives, we’re the fairest, easiest way to manage your money across borders. We’re just at the beginning of our story and growing at an incredible pace. We...
