الوصف الوظيفي
Role and Responsibilities
Regulatory (In Field)
• Assist in preparation of the dossiers for new registration, renewal and variations of the products
• Maintain a full up to date database for tracking the regulatory activities plus organize and update status of the registration process.
• Support the business in filing and documentation tasks when required
• Archives regulatory updates issued by health authorities across the Gulf and Levant
• Provide the monthly regulatory affairs report to the Regional Regulatory Affairs Manager and Managing Director, including registration updates, pending registration, renewals in a dashboard format
• Arrange for regular meetings and alignment with distributors to update on regulatory affairs & registration status
• Maintain an in-house repository of relevant laws and local authority guidelines.
• Responsible for samples request• Assist keeping the internal stakeholders all updated regularly with the progress and any issues requiring re-prioritization and ensure regulatory compliance of all products by contributing to internal reports, document updates
Pharmacovigilance• PV Support in PV activities across the region including PSUR planning, timely PSUR submissions, audit preparation, and responding to questions & labeling updates
المهارات
Education & Experience:
• Minimum of 3 years in Regulatory Affairs and/or Pharmacovigilance and 2-3 years’ experience in Pharmaceutical Industry
• Language skills: Fluent in English and Arabic (Preferred but not Compulsory)
• University Degree preferably in Pharmacy or Veterinary Medicine
• Advanced in Excel and PPT
Leadership Behaviors
• Demonstrate ethics & integrity
• Drive results
• Make rapid, disciplined decisions
• Act with courage and candour• Foster collaboration
Professional Competencies
• Business & Financial Acumen Applying
• Working Across Boundaries Applying
• Strategic Thinking Applying
• Project Management Applying
• Productive Communication Applying• Problem Solving Applying
تفاصيل الوظيفة
منطقة الوظيفة: دبي, الإمارات العربية المتحدة قطاع الشركة: الأدوية طبيعة عمل الشركة: صاحب عمل (القطاع الخاص) الدور الوظيفي: الطب والرعاية الصحية والتمريض نوع التوظيف: دوام كامل الراتب الشهري: غير محدد عدد الوظائف الشاغرة: غير محدد الرقم المرجعي للوظيفة: JB3753822
المرشح المفضل
المستوى المهني: مبتدئ
https://www.bayt.com/ar/uae/jobs/regulatory-affairs-pharmacovigilance-specialist-3753822/