Regulatory Affairs Specialist

الوصف الوظيفي
Specialist with expertise in eCTD submissions for the United Arab Emirates (UAE). The Regulatory Affairs Specialist will be responsible for ensuring compliance with applicable regulatory requirements for submissions of Documents & registration of products with UAE MOH. He or She will be responsible for developing and implementing eCTD submission strategies for our products in the UAE market.

Responsibilities:

• Develop and implement eCTD submission strategies for our products registration & compliance in the UAE market

• Ensure compliance with applicable regulatory requirements.

• Prepare and submit eCTD submissions to regulatory agencies in the UAE.

• Review and interpret regulatory requirements.

• Communicate with regulatory team of principles to coordinate the documentations for registration process.

• Monitor regulatory changes in UAE & update our compliance accordingly.

• Maintain eCTD submission records and documentations.

المهارات
• Bachelor’s degree in a scientific field preferably in Pharmacy or in biology or chemistry

• Minimum of 3 years of experience in regulatory affairs, with a focus on eCTD submissions for the UAE

• Strong knowledge of eCTD submission standards and requirements for the UAE market

• Excellent communication and interpersonal skills

• Strong attention to detail and organizational skills

Preferred Qualifications:

• Master’s degree in a scientific field

• Regulatory affairs certification (RAC)

• Experience with international eCTD submission requirements, such as those of the EU or USA.

تفاصيل الوظيفة
منطقة الوظيفة دبي, الإمارات العربية المتحدة
قطاع الشركة الصيدلة; صناعة الدواء
طبيعة عمل الشركة غير محدد
الدور الوظيفي التمويل والإستثمار
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة 1

https://www.bayt.com/ar/uae/jobs/regulatory-affairs-specialist-4678876/