Regulatory Affairs Specialist
il y a 1 semaine
Regulatory Affairs SpecialistAntwerpen – contractingWhat are your responsibilities?Support regulatory submissions (CTD, BLA, NDA,...) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.Liaise with regulatory colleagues to communicate and resolve potential issues.Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of the company portfolio.Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility.Assess Post approval changes at the manufacturing site and the associated regulatory variations.You are responsible for authoring the impacted sections of the dossier.Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals.Who are you?Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)Minimum 3 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA, CMC) and quality.Scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentationKnowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA)Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.Fluent in Dutch & English (written and spoken)What can you expect?Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply.
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Project consultant Regulatory Affairs
il y a 5 jours
Antwerp, Belgique WhatJobs Temps pleinUSG Professionals zoekt een Project consultant Regulatory Affairs voor onze klant, een wereldwijde leider in innovatieve oplossingen en biedt duurzame productiviteit via geavanceerde compressoren, vacuümoplossingen, generatoren, pompen, powertools en assemblagesystemen. Als Regulatory Affairs Specialist ben je verantwoordelijk voor het waarborgen van...
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il y a 3 semaines
Antwerp, Belgique WhatJobs Temps plein3 days ago Be among the first 25 applicants Direct message the job poster from QbD Group Senior Talent Acquisition Specialist | HR | QbD | Looking for life science professionals to join our team! As part of our continued global expansion, we are seeking an experienced Director Business Development – Pharma to lead and grow our international business...
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Computer System Validation
il y a 3 jours
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il y a 2 semaines
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Principal LC-MS Development Sales Specialist – Food
il y a 2 semaines
Antwerp, Belgique VRS Recruitment Temps pleinPrincipal Sales Development Specialist – Food & Environmental (LC-MS)Location: Belgium (Benelux-based, close to Antwerp)Scope: Northern EuropeFood safety and environmental monitoring are critical, fast-evolving sectors driven by regulatory pressure, public health needs, and increasing analytical complexity. Laboratories across Europe rely on advanced...
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il y a 2 semaines
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il y a 1 semaine
Antwerp, Belgique Vivid Resourcing Temps pleinJob Summary We are seeking an experienced QA associate to join our quality team. The ideal candidate will have a strong background in quality assurance, a keen eye for detail, and a deep understanding of industry regulations. This role is crucial in ensuring our products meet the highest standards of quality and compliance, thereby maintaining customer...
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Quality Assurance Specialist
il y a 1 semaine
Antwerp, Belgique Vivid Resourcing Temps pleinJob SummaryWe are seeking an experienced QA associate to join our quality team. The ideal candidate will have a strong background in quality assurance, a keen eye for detail, and a deep understanding of industry regulations. This role is crucial in ensuring our products meet the highest standards of quality and compliance, thereby maintaining customer...
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Quality Assurance Specialist
il y a 1 semaine
Antwerp, Belgique Vivid Resourcing Temps pleinJob SummaryWe are seeking an experienced QA associate to join our quality team. The ideal candidate will have a strong background in quality assurance, a keen eye for detail, and a deep understanding of industry regulations. This role is crucial in ensuring our products meet the highest standards of quality and compliance, thereby maintaining customer...
