وظائف خالية مشرف شؤون تنظيمية - ( علوم / صيدلة ) - حدائق الأهرام - الجيزة

متطلبات الوظيفة

  • مستوي الخبرة

    مدير / مشرف

  • سنين الخبرة

    4-‎8 سنوات خبرة

  • الجنس المطلوب

    لا يشترط

  • اللغة الانجليزية

    جيد جدا

  • السن المطلوب

    30 - 40 سنة

  • الحاسب الآلي

    جيد جدا

  • المؤهل المطلوب

    مؤهل عالي

  • مايكروسوفت أوفيس

    جيد جدا

الراتب ونوع العمل

  • الراتب الأساسي

    قابل للتفاوض

  • نوع الوظيفة

    يوم كامل

مميزات الوظيفة

  • يُحتسب الوقت الإضافي

تفاصيل الوظيفة

Regulatory Affairs Supervisor

Required to fulfill the following:
1- Responsibilities:
  • Preparation of the regulatory documents required for submission of the annual / complementary Importation Licenses and or importation approvals of FRANCO Products and working closely with the DRA / GRA team to ensure that the documents are valid and complete at the time of submission (CPPs, registration licenses, pricing certificates, variations approvals, etc.)
  • Working with different internal stakeholders in order to receive the documents required for issuing special import licenses for non-registered products (SILs) on timely manner.
2- Submission:
  • Filling in all MOH forms and templates required for submission.
  • Submission of the importation plans / approvals together with all the related documents to the concerned departments at MOH (Registration department – licensing department – importation department).
  • Submission of SILs requests to MOH.
  • Following up and answering MOH queries in timely manner until granting the final approvals and sharing them with all concerned stakeholders
3- Inspection & Release Follow:
  • Follow up on inspection and release visit.
  • Follow up on the release tracker and sample conformity reports tracker.
  • Working closely with supply chain and Department of regulatory Affairs (DRA) release colleagues and providing support to ensure final release / inspection of the upcoming shipments are done on timely manner.
  • Follow up on Health Authority communication in terms of Drug shortage as well as inspection visits schedule.
  • Follow up on reference standards tracker tool.
4- Others:
  • Perform other duties as assigned.
5- Skills:
  • Bachelor of Pharmaceutical Sciences or Science Degree.
  • Minimum 4 years of experience within pharmaceutical industry Experience in regulatory/ importation processes and/or inspection & release of medicinal products.
  • Experience in different types of interaction with regulatory authorities Good planning and organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.
  • Negotiation & Communication Skills.
  • Leadership skills.
  • • Strong interpersonal skills.
  • Good Command of English Language.
  • Computer Skills.
  • Full Time.

وظائف مثل وظيفة "مشرف شؤون تنظيمية - ( علوم / صيدلة )"

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