Regulatory Affairs Specialist
il y a 5 heures
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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Regulatory Affairs Specialist
il y a 6 heures
Antwerp, Belgique Jefferson Wells Belgium Temps pleinRegulatory 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...
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Regulatory Affairs Manager
il y a 2 semaines
Antwerp, Belgique Michael Page Temps pleinRegulatory Affairs Manager - Antwerp - Specialty Chemicals Analyse and interpret regulations for various products and markets. Develop strategies, timelines, and plans for market authorisations. Oversee third-party validation processes. Manage projects within the regulatory affairs scope. Contribute to sustainable product development, including carbon...
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Regulatory Affairs Manager Benelux
il y a 1 semaine
Antwerp, Belgique Elanco Temps pleinResponsibilities:Drive life-cycle management and maintenance of existing products,Ensure successful roll-out of new products,Oversee and align Elanco’s global strategy on a local level,Ensure regulatory compliance to support key business operations,Facilitate strong cross-functional communication with internal and external partners,Proactively prioritize...
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Junior Quality and Regulatory Assistant
il y a 3 jours
Antwerp, Belgique F Care Systems Temps pleinJob descriptionAre you a proactive and detail-driven professional ready to kick-start your career in the medical device industry? Then you might be the person we're looking for!Job Description:At F Care Systems, we're hiring a Junior Quality and Regulatory Assistant to join our team at our Berchem (Antwerp) office. This is a full-time, on-site role—perfect...
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Director Business Development – Pharma
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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Warehouse Supervisor
il y a 2 semaines
Antwerp, Belgique Planet Pharma Temps pleinOne of our most exciting clients are looking for a Team Leader to join our Distribution Centre. In this role, you will oversee the operational processing of outgoing goods, efficiently guide your team's activities, and ensure coordination with other teams within the facility.Key Responsibilities:Coordinate resources for order planning, warehouse operations,...
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Warehouse Supervisor
il y a 2 semaines
Antwerp, Belgique Planet Pharma Temps pleinOne of our most exciting clients are looking for a Team Leader to join our Distribution Centre. In this role, you will oversee the operational processing of outgoing goods, efficiently guide your team's activities, and ensure coordination with other teams within the facility.Key Responsibilities:Coordinate resources for order planning, warehouse operations,...
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Warehouse Supervisor
il y a 2 semaines
Antwerp, Belgique Planet Pharma Temps pleinOne of our most exciting clients are looking for a Team Leader to join our Distribution Centre. In this role, you will oversee the operational processing of outgoing goods, efficiently guide your team’s activities, and ensure coordination with other teams within the facility.Key Responsibilities:Coordinate resources for order planning, warehouse...
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Warehouse Supervisor
il y a 2 semaines
Antwerp, Belgique Planet Pharma Temps pleinOne of our most exciting clients are looking for a Team Leader to join our Distribution Centre. In this role, you will oversee the operational processing of outgoing goods, efficiently guide your team's activities, and ensure coordination with other teams within the facility. Key Responsibilities: Coordinate resources for order planning, warehouse...
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Cyber Security Specialist
il y a 3 semaines
Antwerp, Belgique XQUISIT Temps pleinLOCATION: ANTWERP OR PRAGUE! Group Security is seeking an experienced Cybersecurity Specialist – Mergers & Acquisitions (M&A) with a strong background in evaluating and mitigating cybersecurity risks across all domains, particularly in cloud environments such as Azure and AWS and Entra ID. This role involves conducting comprehensive cybersecurity...
