REGULATORY AFFAIRS SPECIALIST

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Angajator: A&D Pharma
Domeniu:
  • Farmacie - Medicina
  • Tip job: full-time
    Nivel job: 1 - 5 ani experienta
    Orase:
  • BUCURESTI
  • Actualizat la: 10.09.2018
    Scurta descriere a companiei

    A&D Pharma este cel mai mare grup farmaceutic din Romania care include compania Mediplus – lider national in distributia de produse farmaceutice si parafarmaceutice, Sensiblu – cel mai mare lant de farmacii cu acoperire nationala din Romania, lantul de farmacii Punkt, A&D Pharma Marketing&Sales si Fundatia Sensiblu ce se implica activ in proiecte sociale.
    Suntem compania in care pasiunea, creativitatea si perseverenta te conduc spre performanta. Iti oferim un mediu provocator si dinamic in care te poti dezvolta alaturi de echipe de succes si unde tu stabilesti masura impactului pe care il poti avea!
    Accepta provocarea de a face diferenta impreuna!

    Cerinte

    Requirments:
    - University Degree in Pharmacy/Medicine;
    - Minimum 3 years experience in a similar position;
    - Thorough knowledge of the legislation regarding medicines, food supplements, medical devices, cosmetic products authorizations/ notification;
    - Excellent language skills in English;
    - Good Computer proficiency;
    - Dynamic and adaptive personality.

    Responsabilitati

    Responsabilities:
    - Preparing and/or evaluating the documentation files for registration, re-authorization of the products;
    - Following-up of the registration process and all legislative requirements connected;
    - Translating into Romanian all documents required (summary of product characteristics, patient information leaflet, packaging data, etc.);
    - Submitting licence applications and documentation to the authorities to strict deadlines;
    - Performing pharmacovigilance activities.