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Guerbet est un leader mondial de l'imagerie médicale, proposant une large gamme de produits pharmaceutiques, de dispositifs médicaux, de solutions numériques et d'IA pour l'imagerie diagnostique et interventionnelle, afin d'améliorer le diagnostic et le traitement des patients.

Pionnier depuis plus de 90 ans dans le domaine des produits de contraste, Guerbet innove en permanence avec 9% des revenus dédiés à la Recherche & Développement et quatre centres en France, en Israël et aux États-Unis.

Guerbet (GBT) est cotée sur Euronext Paris (segment B - mid caps) et a réalisé un chiffre d'affaires de 817 millions d'euros en 2019 avec plus de 2 800 collaborateurs dans le monde.

Achieve, Coorperate , Care et Innovate  sont les valeurs que les employés de Guerbet partagent et pratiquent chaque jour. Travailler chez Guerbet, c'est jouer un rôle unique dans l'avenir de l'imagerie médicale. Passionnée par son métier, l'entreprise s'efforce jour après jour de conjuguer performance, qualité et développement durable.

Pour plus d'informations sur Guerbet, rendez-vous sur www.guerbet.com  et suivez Guerbet sur Twitter @GuerbetGroup

Regulatory Compliance Manager

Description

In the context of the increase of worldwide authorities regulatory requirements and in order to maintain a high level of regulatory compliance, and anticipate future challenges from worldwide regulatory authorities (EMA, FDA, etc…) Guerbet is looking for a regulatory compliance manager to join the team of Regulatory affairs department. This position is located in Guerbet HeadQuarters, in Villepinte (93).

This Regulatory compliance manager will join the pole Regulatory Compliance and Data Management. We are looking for an enthusiastic and motivated person to bring skills to the team, and who will have the following activities:

  • Guarantee the application of regulatory requirements in the regulatory operations (except CMC part), and in interface of other departments (Pharmacovigilance and Clinical).
  • Participate in audits and inspections related to tasks and activities under responsibility
  • Participate in the End to End labelling compliance process for all manufacturing sites
  • Participate in the serialization project implementation as regulatory contact point
  • Ensure trainings for compliance and data management aspects and tools, including creation/update of related procedures and user guides
  • Ensure a regulatory intelligence for the medicinal product regulatory aspects and data management (update on standards and guidelines: IDMP, CESSP, eAF, ePI …etc)
  • Ensure an expertise and the maintenance of various internal regulatory tools: (EDMS, RIM, etc) in validated and up to date states. This include change requests for tool improvement, upgrades and regulatory processes improvement in interface with admins and key users.
  • Participate in submission to external tools (Article 57, XEVMPD, SPOR database, etc)
  • Participate in the data quality and compliance monitoring

Build KPIs for monitoring of compliance for regulatory affairs department

Compétences requises

Specific requirements (skills) or experience for the assignment?

  • At least, Master degree in scientific domain, Pharmacist preferable
  • Language: fluent English as daily language.  
  • Experience: 3 years in regulatory affairs domain, preferably in Regulatory operations
  • Essential business experience
  • Experience with a pharmaceutical company RIM (Regulatory Information Management) System
  • Autonomy
  • Desired business experience
  • Knowledge of XEVMPD submissions to the EMA is a plus
  • Knowledge of IDMP in the EU is a plus
  • Experience with data structure of medicinal products in the world
  • Experience with EDMS (Electronic Document Management System)

Experience with SharePoint and Excel

Formation