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القانوني والامتثال · وصف وظيفي

Regulatory Affairs Officer

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. In the GCC market, this role is actively hired across kuwait, uae with 2 recent postings.

إعلانات الخليج
2
الأسواق النشطة
2
الخبرة المعتادة
1-2 years
لمحة عن الراتب

كم يتقاضى Regulatory Affairs Officer في الإمارات

الوسيط الشهري الإجمالي بالدرهم لوظيفة Regulatory Affairs Officer بمستوى متوسط. اطّلع على التفصيل الكامل حسب الدولة ومستوى الخبرة.

المئوية 25
18,000
الوسيط
27,500
المئوية 75
40,000
اطّلع على نطاقات الرواتب ←
المهام الرئيسية
  • 01vigilance activities Prepare pharma co
  • 02related tasks as directed by the Direct Manager.
  • 03Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • 04Review all regulatory agency submission materials to ensure timeliness, accuracy, completeness, or compliance with regulatory standards.
  • 05Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • 06Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • 07Provide responses to regulatory agencies regarding product information or issues.
  • 08Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • 09Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • 10Manage activities such as audits, regulatory agency inspections, or product recalls.
  • 11Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • 12Maintain current knowledge of relevant regulations, including proposed and final rules.
المؤهلات المطلوبة
  • and product safety standards. Maintaining accurate and up
  • date regulatory documentation, records, and files. Acting as a point of contact for regulatory authorities and participating in regulatory meetings or discussions. Collaborating with cross
المؤهلات المفضّلة
  • Bachelors Degree or Higher Additional Information Pharmacy background is preferred but not essential
المؤهلات التعليمية
  • Bachelor's degree

الأدوات والتقنيات

teamsAdlib ExpressAdobe AcrobatAnalyse-itAris Global RegisterAxway eSubmissionsDatabase softwareDatafarm a-PulseDatafarm eCTDGatekeeperDatafarm eCTDViewerDatafarm S-CubedDialog DialogLinkDocument publishing softwareDoubleBridge ROSETTA Phoenix eCTD ViewerDoubleBridge ROSETTA PyramidDoubleBridge ROSETTA Sceptre

شركات نرى أنها توظّف

  • Ghobash Group
  • Mohamed N. Al Hajery and Sons Co. LTD

التوظيف حاضر في

  • kuwait
  • uae