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Job ID R-439135 Date posted 10/07/2022 BACK TO SEARCH RESULTS Apply

Senior Regulatory Affairs Specialist (Hybrid - Télétravail partiel)

Job Description Summary

L’entité BD Medical - Pharmaceutical Systems conçoit, développe et industrialise un vaste portefeuille de seringues préremplies, de systèmes d'auto-injection, de solutions de sécurité et de protection.
Au sein de l’équipe Affaires Réglementaires, nous recherchons un Senior Regulatory Affairs Specialist.
En collaboration avec les équipes transversales (ventes, qualité, SC et marketing) et avec le soutien de fonctions techniques (médical, R&D et qualité), votre mission consistera à accompagner des clients globaux et régionaux basés aux US.
(English version will follow)

Job Description

Vous apportez un support à vos clients :

  • en les aidant dans la compréhension des exigences relatives aux produits combinés,
  • en les soutenant activement lors des phases de dépôt de dossiers (soumissions, variations, renouvellements, réponse aux questions des Autorités de Santé et Organismes Notifiés)
  • en leur proposant des solutions personnalisées et adaptées à leur besoin.
  • Vous allez au-delà de la « simple » réponse à leurs questions en leur proposant des solutions différenciantes (sessions de formation aux nouvelles réglementations internationales, support dans les meetings avec les autorités de santé et organismes notifiés, aide à l’évaluation des changements, etc.)

Votre expérience :

  • Bac+5 en sciences (Pharmacien, Master, Ingénieur, Doctorat)
  • 5 ans d'expérience en Affaires Règlementaires dans l’Industrie Pharmaceutique ou des Dispositifs Médicaux.
  • Vous avez participé à des soumissions de dossiers d’enregistrement ou de variations auprès des Autorités de Santé (Europe ou US)
  • Vous avez une bonne compréhension du marché de l’industrie pharmaceutique. 
  • Vous savez arbitrer les priorités et gérer plusieurs projets/clients de front
  • Vous savez naviguer dans une structure matricielle, créer votre réseau interne/externe
  • Vous avez une forte capacité de communication, interne/externe pour être ambassadeur de la fonction réglementaire
  • Vous avez un très bon niveau d’anglais (oral/écrit)
  • Ryhme télétravail hebdomadaire : 2 jours sur site / 3 jours télétravail

English Version

BD Pharm System provides industry-leading needle technologies, prefillable syringes, safety and shielding systems, and self-injection systems for pharmaceutical and biotech companies across the globe.

We are recruiting a Senior Regulatory Affairs Specialist to join our team in Franklin Lakes (US) or Pont de Claix (France).

As Senior Regulatory Affairs specialist for the Pharmaceutical Systems Regulatory Affairs team, your mission, in collaboration with a cross-functional customer-facing team (sales, quality, supply & marketing) and with the support of technical functions (medical, R&D & quality) is to support pharmaceutical customers located in the US and in particular:

Your mission

  • Provide fast & accurate solutions to customer registration challenges (submission, variations, response to questions) in key geographies targeted by customers, mainly US markets.
  • Deliver unique regulatory affairs Services.
  • Advice on "regulations" related to injection systems, projects of new drug development or changes in primary packaging.
  • Personalize customized support in the preparation of registration files.
  • Answer to questions from Global Health Authorities and support for the management of change/variation.

Your background:

  • You are a Pharmacist or Engineer; you have a minimum of 5 years proven experience ideally in Regulatory Affairs within a medical device or drug industry. Ideally, you have participated in the submission of new registration files or variations to Health authorities in EU, US and/or another key-geography.
  • You are solution-oriented, can arbitrate priorities and are comfortable prioritizing multiple projects simultaneously.
  • Excellent communicator, you know how to be an ambassador for the Regulatory Affairs function.
  • Your team spirit and customer relationship management allows you to develop your network with internal and external counterparts.
  • You are proficient in English.

Primary Work Location

FRA Le Pont-de-Claix Cedex

Additional Locations

USA NJ - Franklin Lakes

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