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    Regulatory Affairs Officer - Paris, France - Groupe ProductLife

    Groupe ProductLife
    Groupe ProductLife Paris, France

    il y a 1 semaine

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

    • Regulatory Affairs
    Permanent contract

    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.

    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.
    Education At least a Bachelor's Degree in Life Sciences. Ideally a Pharmacy Degree (PharmD).
    Experience At least 1-2 years' experience in Regulatory Labelling Operations in a Pharmaceutical Company or Service Provider

    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
    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 #J-18808-Ljbffr
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