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Regulatory Affairs Specialist
Il y a 2 mois
Depuis 1993, ProductLife Group (PLG) accompagne ses clients tout au long du cycle de vie des produits des sciences de la vie, combinant expertise locale et portée mondiale et couvrant plus de 140 pays.
PLG est une société de conseil en sciences de la vie qui fournit des services externalisés dans les domaines des affaires réglementaires, de la qualité et de la conformité, de la vigilance et de l'information médicale.
Notre expertise s'étend à la fois à la surveillance des produits établis et aux thérapies et diagnostics innovants.
Vous aurez pour missions de :
- Apporter un soutien aux clients pour la gestion des soumissions et tous autres demandes réglementaires pour les territoires requis/assignés
- Contribuer aux activités réglementaires réalisées en pré AMM (préparation des documents du Module 1 pour les nouveaux enregistrements) et post AMM (activités du LCM) Aider à la préparation des demandes d'autorisations de mise sur le marché (AMM)
- Préparation, compilation et soumission de la documentation pour les demandes post-AMM, y compris, mais sans s'y limiter, les variations de type IA, de type IB, de type II, les renouvellements, transferts d'AMM (MAH Transfer), etc.
- Préparation et soumission des demandes de transfert technique/de site industriel
- Documenter et suivre les soumissions réglementaires et l'approbation de l'autorité réglementaire Suivi des demandes d'AMM, et réponse aux questions auprès des autorités de santé
- Elaboration, validation, diffusion et mise à jour des textes relatifs aux articles de conditionnement et à l'information produit: examen et modification des textes du packaging primaire et secondaire, y compris du SmPC et du PIL.
- Veille réglementaire et scientifique nationale et internationale
- Veiller au respect de tous les processus réglementaires, en vue des audits internes et externes Utiliser divers progiciels pour produire de la correspondance et des documents, tenir à jour des feuilles de calcul et des bases de données, et localiser des informations et des données, par exemple Microsoft Office Suite, Veeva Vault (ou un système de GED comparable), LorenZ, Trackwise, PromoMat, etc.
- Gestion et alimentation des bases de données réglementaires internes et externes
- Archivages des dossiers d'AMM et des informations réglementaires
Profil recherché:
Vous avez un Bac +5 dans le domaine de la santé
De plus vous avez :
- Minimum 5 ans d'expérience sur un poste similaire en Affaires Réglementaires
- Maîtrise des exigences réglementaires associés
- Rigueur et autonomie
- Capacité d'analyse et de rédaction
- Bonne capacité de communication interpersonnelle
- Anglais courant exigé
Avantages :
- Management de proximité, ambiance dynamique et stimulante
- Avantages sociaux (Mutuelle, Carte Ticket Restaurant, Bonus, Congés Payés, Prise en charge du transport, Remboursement des frais liés aux déplacements professionnels.)
Pourquoi rejoindre PLG ?
- Société Internationale
- Multi-Projets sur divers types d'activité en pharma, cosmétique, biotech et médical
- Projets de grande envergure/auprès de clients à renommée internationale
- Montée en compétences /Career Path/ Academie PLG
- Une équipe dynamique et motivée Les valeurs d'Intégrité, Transparence, Qualité, Confiance, Efficacité, Responsabilité et Engagement sont importantes pour vous. Rejoignez-nous
