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    Regulatory Affairs Specialist - México - Groupe ProductLife

    Groupe ProductLife
    Groupe ProductLife México

    hace 21 horas

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    Descripción

    In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM.

    Responsibilities

    • Provide guidance and support about Mexican and Central America legislation
    • Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
    • Contribute to the production of client administrative documents to be included in regulatory submissions
    • Compile regulatory dossiers in accordance with national requirements.
    • Systems Management and Administration
    • Document and track regulatory submissions and regulatory authority approval.
    • Provide regulatory support to clients and associate companies
    • Liaise with sponsor head-office and affiliate departments on regulatory issues.
    • Provide review of packaging texts.
    • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
    • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

    Education & Experience

    • Bachelor's degree or more in a Life Sciences related field. Pharmacy degree would be a plus.
    • 5+ years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider

    Profile

    Hard/Technical skills:

    • Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in LATAM
    • Knowledge of MX and LATAM (Guatemala, Panama, Dominican Republic) regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
    • Good understanding of data and document management systems, MS Office applications
    • New registrations of drug products is preferable.
    • Excellent organizational and interpersonal skills
    • Ability to work well within a team and autonomously
    • Ability to prioritize different workloads/multi-task
    • Ability to deliver on tight timelines
    • Process orientated with good attention to detail
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