Regulatory Affairs Officer

الوصف الوظيفي
Wellpharma Medical Solutions ,UAE is looking for RA officer.

Gathering , evaluating, organizing, managing and collating information in a variety of formats.
Planning , undertaking and overseeing product trials and regulatory inspections.
Keeping up to date with changes in regulatory legislation and guidelines.
Analysing complicated information, including trial data.
Offering advice about company policies, practices and systems.
liasing and negotiating with regulatory authorities.
Providing advice about regulations to manufacturers/scientists.
Writing comprehensible, user-friendly, clear product information leaflets and labels.
Ensuring that quality standards are met and submissions meet strict deadlines
Module 3 review of new product for filing, document arrangement for filing, generating documents for filing and maintenance of document.
Follow up for DDC codes, DDC codes filing.
Apply Import/Export permit and shipment clearance, document arrangement, filing.
Staff License update and control.
CPP , Product registration, Product renewal, new product update and control.
Regulatory related approval, fillings, Site registration, Endorsement letter, Shelf life update.
المهارات
Pharma Degree with 5 -7 years of UAE experience in Regulatory body
Fluent in English an Arabic
تفاصيل الوظيفة
منطقة الوظيفة أبوظبي, الإمارات العربية المتحدة
قطاع الشركة صناعة الدواء
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي مراقبة الجودة
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
المرشح المفضل
المستوى المهني متوسط الخبرة
عدد سنوات الخبرة الحد الأدنى: 5
منطقة الإقامة الإمارات العربية المتحدة

https://www.bayt.com/ar/uae/jobs/regulatory-affairs-officer-4192131/