Global Regulatory Lead
Il y a 6 mois
**Mission**:
- Soutien aux Global Regulatory Leads
- Membre des équipes Global Regulatory
- Participer à la création et à l’exécution de la stratégie réglementaire globale pour les produits
- Participer à la définition du contenu du dossier d’enregistrement et de gestion du cycle de vie.
**Participer à la stratégie réglementaire**
- Comprendre les principales caractéristiques des produits, les tendances réglementaires pertinentes et la concurrence dans les principaux marchés (p. ex., lignes directrices, précédents) nécessaires pour évaluer les résultats des stratégies réglementaires tout au long du cycle de vie des produits. p. ex., nouvelle génération de preuves, voies accélérées, orphelin, fondement juridique ).
- Participer à la collaboration entre les parties prenantes internes (p. ex., la sous-équipe clinique) pour créer et maintenir la stratégie réglementaire globale d’indication/projet alignée sur le document de stratégie réglementaire
- Participer à la stratégie réglementaire de l’indication/du projet (p. ex., ODD, enregistrement, LCM) et aux principales interactions des autorités sanitaires (p. ex., EMA, FDA, PMDA, CDE) en étroite collaboration avec les RRLs/LRA (point de contact principal)
- Participer à l’élaboration de l’étiquette de l’indication ou du projet (p. ex., renseignements sur le produit) et de la fiche technique de base de l’entreprise (CCDS), en collaboration avec les représentants de l’étiquetage.
- Participer à la conception du plan de soumission réglementaire, en collaboration avec la direction des soumissions et les responsables régionaux
- Membre principal de l’équipe réglementaire mondiale.
- Participer au dossier de référence de l’indication/du projet et superviser les mises à jour pour les extensions de ligne, l’expansion du marché et/ou les variations.
- Veiller à l’uniformité et à la livraison en temps opportun de la documentation réglementaire pour l’indication/le projet tout au long du cycle de vie (p. ex., documents CTA/IND, cahier d’information de base, jeu de diapositives, questions et réponses, PIP/PSP, modules CTD) afin de respecter les délais de soumission.
- Participer à l’élaboration et à la tenue à jour du registre des risques réglementaires pour appuyer les équipes d’indication et de projet.
- Fournir un soutien à RRL/LRA sur les marchés clés pour faciliter les procédures d’enregistrement.
**CTA/IND (pour indication/projet)**
- Dans le cas des CTA/IND, s’assurer que la documentation réglementaire disponible satisfait aux exigences nécessaires à la mise en œuvre de l’étude (p. ex., études toxicologiques réglementaires)
- Participer à l’étude d’impact de la réglementation en cas de nouvelles découvertes (qualité, efficacité ou sécurité)
**PROFIL**
- **3 ans en réglementaire**:
- Organisé(e) et autonome
- Capacité à gérer simultanément plusieurs activités
- **Anglais courant**
Type d'emploi : CDI
Statut : Cadre
Rémunération : 35 917,00€ à 39 541,00€ par an
Avantages:
- Flextime
- Intéressement et participation
- Prise en charge du transport quotidien
- RTT
Programmation:
- Du lundi au vendredi
Types de primes et de gratifications:
- Prime annuelle
Question(s) de présélection:
- Quelles sont vos prétentions salariales (montant fixe annuel brut ou fourchette annuelle brut) ?
Lieu du poste : Télétravail hybride (92400 Courbevoie)
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