Regulatory Affairs Specialist

- Mendrisiotto - Svizzera

  • Informazioni generiche

    Occupazione al 100%. Contratto indeterminato.

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    We are seeking a Regulatory Affairs Specialist for our client, a very importan international industry based in the beautiful Mendrisiotto area.  


    POSITION SUMMARY
    The Regulatory Affairs Specialist will provide regulatory support to ensure regulatory compliance and obtain national and international authorizations and their lifecycle maintenance under the direct control of a supervisor.

    TASKS AND RESPONSIBILITIES
    • Support the preparation, submission, and maintenance of world-wide product registrations in the main global National and International Markets.
    • Critically and autonomously prepare/revise the regulatory documentation for registration purposes (MAA, variations, renewals, etc.) intercommunicating with internal departments, local partners/MAHs, and external consultants.
    • Constantly remain updated on new regulations issued by HAs and other regulatory organizations.
    • Review product labeling for compliance with global labeling regulations.
    • Ensure the registration documents are prepared and kept updated according to the regulatory requests of each relevant Health Authority.
    • Collaborate with the Quality Assurance and Pharmaceutical Development department to assess the regulatory impact of Change Controls according to the internal SOP.
    • Ensure that the national texts of Company products are regularly updated and uploaded to national databases, where necessary, either directly or through local partners or consultants.

    KNOWLEDGE AND SKILLS
    • 5-year degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology)
    • At least 4-5 years' regulatory affairs experience
    • Deep knowledge of pharmaceutical legislation and regulations
    • Experience in EU registration procedures (MRP/DCP MAA, post approval changes, extensions, and renewals).
    • Preferably previous experience with global registrations
    • Preferably CMC (quality part of the dossier) knowledge
    • Very good English communication and writing skills (knowledge of French or German would be an asset)
    • Organizational skills and regulatory project management skills
    • Ability to resolve conflicts and develop a course of action leading to beneficial outcomes
    • Cultural awareness and sensitivity to achieve results across regional, national, and international borders
    • Commitment to continuous improvement

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