Regulatory Affairs Coordinator

الوصف الوظيفي
• Reviewing & compiling dossiers for registration/ re-registration/ variation for sites and products across Middle East region.
• Following up actively on all dossier submissions
• Endeavouring constantly to anticipate and respond to regulatory/ technical queries
• Achieving timely market-driven product submissions and registration approvals
• Meeting product re-registration deadlines for marketing authorisation renewals

• Maintaining an informed awareness of regulatory guidelines
• Coordination and communication between the corporate RA team and the distributors.
• Compilation of data for tender applications as requested by Marketing
• Archiving and maintenance of registration related documents & certificates
• Preparation, follow up and revision of new or modified artworks text
• Ensure that Artwork changes are approved & implemented on time to meet MOH commitments and local / corporate compliance guidelines

المهارات
Experience and Knowledge
• Pharmacist (preferred) or degree holder in Chemistry or Life Sciences
• Preferably having had a technical education in Arabic
• Fluency in written and verbal English and Arabic is an add
• Minimum 1 year experience in pharmaceutical regulatory affairs in the Middle East
• A good working knowledge of Middle East regulatory requirements in Conventional and general sale product
• Knowledge of Pharmacovigilance procedure will be an advantage.
• Computer literate, familiar with computer based information systems, and new electronic documentation systems
Functional/Professional Competencies:
• Organised with a keen eye for detail
• Sound personal and interpersonal management skills
• Analytical skills, accuracy and reliability
• Excellent planning, co-ordination and multi-tasking skills
• Effective communicator, both verbally and in writing
• Works well individually and within a team environment
• Strong capability to work under pressure & self-motivated
• Appreciation of cultural diversity
• Energetic, self starter, and enjoys the thrill of the chase
• A problem-solver, full of good ideas, and wants to make a mark

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 2
المرشح المفضل
المستوى المهني متوسط الخبرة
عدد سنوات الخبرة الحد الأدنى: 1 الحد الأقصى: 3
منطقة الإقامة دبي,الإمارات العربية المتحدة
الشهادة بكالوريوس/ دبلوم عالي
التعليم
Pharmacy, Chemistry or Life Sciences

*** تقدم على الرابط التالي : Apply on the following link ***
https://www.bayt.com/ar/uae/jobs/regulatory-affairs-coordinator-3914038/