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القانوني والامتثال · وصف وظيفي

Principal Regulatory Compliance Specialist

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. In the GCC market, this role is actively hired across saudi with 3 recent postings.

إعلانات الخليج
3
الأسواق النشطة
1
الخبرة المعتادة
5-7 years
لمحة عن الراتب

كم يتقاضى Principal Regulatory Compliance Specialist في الإمارات

الوسيط الشهري الإجمالي بالدرهم لوظيفة Principal Regulatory Compliance Specialist بمستوى متوسط. اطّلع على التفصيل الكامل حسب الدولة ومستوى الخبرة.

المئوية 25
24,000
الوسيط
36,000
المئوية 75
52,000
اطّلع على نطاقات الرواتب ←
المهام الرئيسية
  • 01Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • 02Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • 03Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • 04Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • 05Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • 06Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • 07Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • 08Coordinate recall or market withdrawal activities as necessary.
  • 09Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • 10Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • 11Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • 12Identify relevant guidance documents, international standards, or consensus standards.
المؤهلات التعليمية
  • — Professional Certification

المهارات المطلوبة

communicationcloudauditcomplianceexceloracleproject managementerp

المهارات المفضّلة

risk managementisoReading ComprehensionActive ListeningWritingSpeakingCritical ThinkingActive LearningLearning StrategiesMonitoringSocial PerceptivenessCoordination

الأدوات والتقنيات

oracleexcelerpteamsAdobe AcrobatAnalyse-itAtrion Intelligent AuthoringDataVisionFileMaker ProFund accounting softwareHealthcare common procedure coding system HCPCSHuman resource management software HRMSIntegrated development environment IDE softwareLexisNexisMcAfeeMedical procedure coding software

شركات نرى أنها توظّف

  • Oracle - Egypt
  • Oracle

التوظيف حاضر في

  • saudi
اطّلع على نطاقات الرواتب ←افتح في مولّد الوصف الوظيفي ←
أدوار ذات صلة

المزيد من الأدوار في القانوني والامتثال

أدوات مجانية · 04

أدوات مجانية إضافية

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