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    Regulatory Affairs Officer - Courbevoie, France - ProductLife Group

    ProductLife Group
    ProductLife Group Courbevoie, France

    il y a 1 semaine

    Default job background
    Permanent contract
    Description

    Regulatory Affairs Officer / Linguistic Review Coordinator M/F - 025

    To ensure and coordinate the Linguistic Review (LR) for the Centralized products of one of our key clients, we are urgently looking for a Regulatory Affairs Officer / Linguistic Review Coordinator based in the EU to join our internal teams.

    About us Group 10 Responsibilities
  • Coordinate and manage the Labelling team in charge of the Linguistic Review for the products of one of our key clients
  • Contribute to labelling related regulatory activities related to the Linguistic Review process for Centralized Procedure (CP) medicinal products (linguistic reviews for new MAA's and post licensing changes)
  • Manage the relationship with the Translation partner and manage the translation tool to facilitate the review and coordination of Linguistic Review processes with internal and external stakeholders.
  • Provide ongoing support to the project teams to ensure project concerns are planned and accounted for.
    • Group 11 Education
  • At least a Bachelor's Degree in Life Sciences. Ideally a Pharmacy Degree (PharmD).
    • Group 12 Experience
  • At least 1-2 years' experience in Regulatory Labelling Operations in a Pharmaceutical Company or Service Provider
    • Group 13 Skills

    Hard/Technical skills:

  • Good knowledge of regulatory labelling procedures.
  • Experience in Project Coordination/Management
  • Ideally experience in Line Management
  • Good IT skills/knowledge and the ability to learn appropriate softwares
  • Good understanding of Microsoft Suite

    • Soft skills:

  • Fluent English is mandatory, including excellent grammar skills (written and verbal fluency)
  • Excellent organizational and interpersonal skills
  • Excellent oral and written communication skills, including facing the client
  • Ability to work well within a team and autonomously
  • Ability to prioritize different workloads/multi-task
  • Ability to deliver on tight timelines
  • Personal responsibility for ensuring a high standard of work
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