Gestionnaire Regulatory Affairs

Il y a 4 mois


Wavre, Belgique Laboratoire Huckert’s International Temps plein

Le Laboratoire HUCKERT’S International, Laboratoire innovant et présent à l’international. Spécialiste de la bio-décontamination et de la désinfection de haut niveau en milieu médical, pharmaceutique et technologie de pointe recherche pour une entrée immédiate:
**GESTIONNAIRE REGULATORY AFFAIRS (H-F)**

Bilingue Français/ Anglais

Localisation Géographique: Wavre - Belgique

Vous êtes en charge des Affaires Réglementaires (directives MDD, Règlements MDR, BPR, et Cosmétique).

**Mission**
- Assurer la conformité aux différents règlements en vigueur selon la gamme de produits.
- Soumettre les dossiers d’enregistrement et de variation des produits du Laboratoire Huckert’s International aux autorités compétentes, conformément aux procédures réglementaires et à la législation en vigueur.
- Assurer le maintien des autorisations/notifications d’AMM auprès des autorités réglementaires (MOH) dans l’ensemble des pays développés (Middle East, Europe, Asia..)
- Préparer et valider les informations packaging ainsi que les documents promotionnels en collaboration avec les services : commercial et marketing/communication selon la réglementation en vigueur.
- Assurer le suivi et l’encadrement des stagiaires.
- Assurer la formation Réglementaire du personnel, des clients, de nos distributeurs etc
- Participer et présenter notre laboratoire sous le registre du réglementaire lors de manifestations, congrès, expositions et réunions d’information.
- Suivi des dossiers en cours auprès de nos prestataires réglementaires.
- Participer et défendre les intérêts du laboratoire lors de colloque auprès du DETIC/CQHN et autres fédérations/associations.
- Assurer le Marketing post surveillance des marchés afin de répondre aux exigences réglementaires.
- Participer aux réunions de projets et de développement de produits pour la partie réglementaire.
- Participer au Board de direction.
- PRRC pour la partie réglementaire.
- Participation aux audits externes/internes.

**Vos qualifications**
- De formation scientifique (Biochimie, Biotechnologie, Biologie ) de niveau bachelier au minimum.
- **Avoir une première expérience significative de minimum 5 ans dans le domaine des Affaires Réglementaires**et dans un environnement similaire serait un plus.
- Très bon niveau d’anglais (oral et écrit)
- La connaissance du marché des désinfectants serait un plus.
- Vous êtes intrapreneur : esprit d’équipe, esprit d’analyse, organisé, rigoureux, axé résultat
- Capacité rédactionnelle et de synthèse.
- Thinking out of the box
- Excellente présentation.
- Facilité d’éloquence.

**Offre**
- Salaire en adéquation avec votre profil



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