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דרושים: Regulatory Affairs Specialist

  • Regulatory Affairs Specialist שם החברה: טבעמיקום המשרה: חולון Teva’s Regulatory Affairs team located at Petach Tikva are seeking for a Regulatory Affairs Specialist, who will be responsible for all the supporting activities related to registration and maintenance of Drug Master Files – Electronic submissions, Documents filing, systems update. The role includes:
    Responsibility to prepare and submit the electronic submissions according to industry guidelines
    Proactively collaborates with the Regulatory Associate team members in support activities related to development, registration and maintenance of Drug Master Files, i.e.:
    •Printing and sending DMFs / DL response by hard / soft copy / electronically / eCTD gateway
    •Filling deficiency letters’ response in the SmarTeam/any relevant folder
    Answering customers’ requests asking for LoAs, DMFs, CEPs
    •LoA: Preparation and providing to the relevant MoHs and customers
    •DMFs/CEPs: Sending to the relevant MoHs and customers
    •Deficiency letters responses: Sending to the relevant MoHs and customers and fi
    דרישות:
    Teva’s Regulatory Affairs team located at Petach Tikva are seeking for a Regulatory Affairs Specialist, who will be responsible for all the supporting activities related to registration and maintenance of Drug Master Files – Electronic submissions, Documents filing, systems update. The role includes:
    Responsibility to prepare and submit the electronic submissions according to industry guidelines
    Proactively collaborates with the Regulatory Associate team members in support activities related to development, registration and maintenance of Drug Master Files, i.e.:
    •Printing and sending DMFs / DL response by hard / soft copy / electronically / eCTD gateway
    •Filling deficiency letters’ response in the SmarTeam/any relevant folder
    Answering customers’ requests asking for LoAs, DMFs, CEPs
    •LoA: Preparation and providing to the relevant MoHs and customers
    •DMFs/CEPs: Sending to the relevant MoHs and customers
    •Deficiency letters responses: Sending to the relevant MoHs and customers and fi
    מס' משרה: 1055006 הגשת מועמדות פעולות נוספות שלח בדוא"ל עוד מהחברהנתקלת בבעיה? שיתוף שלח לחבר
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