Regulatory Affairs Specialist Cmc

il y a 1 semaine


Lyon, France Warman O'Brien Temps plein

Dans la continuité du développement des activités du groupe, nous recherchons un(e) Chargé(e) d'affaires Réglementaires CMC sénior afin de renforcer les équipes.

Vous allez avoir des missions variées, travaillant sur la zone Europe pour l’enregistrement des nouveaux produits, ainsi que la gestion du cycle de vie du médicament.

Travaillant sur la partie CMC (Module 2.3 & 3) ainsi que le Module 1 pour les soumissions, vous allez avoir un rôle assez transverse que cela soit en interne (AQ, R&D, clinique, Réglementaire ) comme en externe (CRO, site de production ).

**Vos Missions**
- Participation à la stratégie Réglementaires du portefeuille de produit qui vous sera attribué.
- Coordonner les activités Réglementaires pour les nouveaux produits.
- Rédaction des modules 2.3 & 3 ainsi que la gestion des variations, renouvellement
- Coordonner la constitution des dossiers d’enregistrements ainsi que la soumission des dossiers d’AMM.

**Votre expérience**
- Issue d'une formation scientifique, vous avez une expérience d'au moins 5 ans sur la gestion du module 3: Rédaction, variation...
- Une expérience sur la zone Europe serait l’idéal (DCP, CP)
- Vous parlez français et Anglais.

Se lancer dans cette aventure, c'est rejoindre un groupe familial ou des opportunités en interne peuvent se présenter. C’est surtout un groupe où vous allez pouvoir vous exprimer, gagner en autonomie et développer vos compétences.

Je vous invite à me faire suivre votre CV afin d'échanger ensemble.

Type d'emploi : Temps plein, CDI

Salaire : 47 000,00€ à 52 000,00€ par an

Avantages:

- RTT
- Travail à domicile

Programmation:

- Du Lundi au Vendredi

Types de primes et de gratifications:

- 13ème Mois
- Prime annuelle
- Primes

Lieu du poste : Télétravail hybride (Lyon)



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