Regulatory Affairs Officer Jobs In Dubai UAE

1 week ago


Dubai, Dubai, United Arab Emirates Nathan & Nathan Full time
Regulatory Affairs Officer Jobs In Dubai UAE | Nathan & NathanFor More Top Organization Jobs Click HereWe are hiring a Regulatory Affairs Officer for a Pharmaceutical industry client to join their team in Dubai

Responsibilities:


Responsible for coordinating and preparing CTD/eCTD submission package in accordance with regulatory requirements, and ensuring that submission is complete, accurate, and submitted on timeResponding to regulatory queries and maintaining compliance with regulatory requirements throughout product lifecycle.

Responsible for preparation, submission, and maintenance of regulatory dossiers for new and existing drugs.
Support Pharmacovigilance Department (or Drug Safety Department) in fulfilling obligations for reporting side effects.

Train colleagues in marketing and sales departments, as well as medical and clinical departments on compliance with their reporting responsibilities for Drug Safety.

Processing all products registration according to applicable Company Policies and Standard Operating Procedures (SOP's), and as required by Health Authority

Requirements:
2-5 years experience in regulatory affairs and experience in regulatory standards.
Must have a pharmacist background in the pastGood knowledge of Mohap and Montaji PlatformArabic speaking preferred.
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