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Automatically translated from French. View the original offer
The customer is looking for a confirmed Product Registration Assistant to strengthen their Regulatory Affairs & Compliance team. As part of the Regulatory Affairs Manager, you create and track product registration records, from initiation to finalization, ensuring reliability and compliance.
Rigorous and organized profile, with an excellent sense of follow-up.
Prepare and compile Marketing Authorisation (MA) application files for product registrations and variations. Verify, organize and rebuild the Table of Contents of CTD files received from manufacturers, ensuring their completeness and regulatory compliance. Review and organize the modules of supporting files and documents prior to submission, and prepare Module 1 documents according to country-specific requirements. Keep track of files: status, submissions, approvals and regulatory correspondence. Proactively request, collect and track materials from manufacturers and stakeholders, including following notifications or letters of deficiencies from authorities. Coordinate with the Designer and manufacturers the preparation of mock-ups, as well as the ordering, tracking and delivery of product samples. Candidate profile Control of CTD records and regulatory requirements for product registration (AMM, variations, Module 1). Excellent level of oral and written English, daily oral communication Excellent level of French both orally and in writing. Good knowledge of the preparation and submission phases of regulatory files. Bachelor in Life Sciences, Pharmacy, Regulatory Affairs, Business Administration. Sensitivity to inter-team coordination (manufacturers, graphic designers, logistics partners). Rigor, autonomy and a sense of detail, with the ability to read and analyze quotes.
Excellent level of English French Hours: Monday to Friday Remuneration according to profile Outokia is recruiting: Product Registration Assistant, Freelance, working from Madagascar. Expected profile: Bac+3 minimum. Duties Prepare and compile Marketing Authorisation (MA) application files for product registrations and variations. Verify, organize and rebuild the Table of Contents of CTD files received from manufacturers, ensuring their completeness and regulatory compliance. Review and organize the modules of supporting files and documents prior to submission, and prepare Module 1 documents according to country-specific requirements. Keep track of files: status, submissions, approvals and regulatory correspondence. Proactively request, collect and track materials from manufacturers and stakeholders, including following notifications or letters of deficiencies from authorities. Coordinate with the Designer and manufacturers the preparation of mock-ups, as well as the ordering, tracking and delivery of product samples. Candidate profile Control of CTD records and regulatory requirements for product registration (AMM, variations, Module 1). Excellent level of oral and written English, daily oral communication Excellent level of oral and written French. Good knowledge of the preparation and submission phases of regulatory files. Bachelor in Life Sciences, Pharmacy, Regulatory Affairs, Business Administration. Sensitivity to inter-team coordination (manufacturers, graphic designers, logistics partners). Rigor, autonomy and a sense of detail, with the ability to read and analyze quotes.
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Assurer le support administratif des activités de production en garantissant la gestion, le suivi et la traçabilité des documents de production. Veiller à la fiabilité des données enregistrées, à la mise à jour des outils de suivi, ainsi qu au classement et à l archivage des dossiers de production, afin de contribuer à
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🎯 Responsabilités L assistant de production travaille sous la responsabilité directe de la directrice de production. Il collabore avec le superviseur agricole chargé de l approvisionnement en matières premières et avec la responsable production qui gère la fabrication proprement dite. 📋 Missions principales Aider la
Assurer le suivi des plannings et de l avancement des projets Mettre à jour les tableaux de bord et des outils de suivi Organiser les réunions et rédiger les comptes rendus Assurer le suivi des plans d actions et des livrables Gérer la documentation technique et administrative (GED) Faciliter la coordination entre les