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Regulatory Affairs Associates
Dawa Life Sciences recrute un(e) Regulatory Affairs Associate pour renforcer son équipe. Ce poste à temps plein est basé au Kenya et relève du secteur pharmaceutique.
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Préparer, examiner et soumettre les dossiers de produits, et les téléverser correctement sur le portail de chaque autorité. Gérer les variations et renouveler les licences de produits à temps afin que nos produits restent sur le marché. Coordonner la conception et l'approbation des maquettes d'emballage, des étiquettes, des notices et des dépliants, en veillant au respect des règles d'étiquetage de chaque pays. Travailler avec les équipes Production, PD, QA et QC sur les BMR, les données de stabilité, les rapports de validation et les méthodes d'analyse afin que nos dépôts correspondent à ce que nous faisons réellement. Suivre les évolutions réglementaires pharmaceutiques au Kenya et dans la région, et conseiller l'entreprise en amont sur leurs implications. Être le
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