Regulatory Affairs Officer

Dubai, United Arab Emirates

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We 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 time
Responding 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

QUALIFICATIONS

2-5 years experience in regulatory affairs and experience in regulatory standards.
Must have a pharmacist background in the past
Good knowledge of Mohap and Montaji Platform
Arabic speaking preferred.
Preference will be given to immediately available candidates.
Knowledge of Microsoft Excel and Microsoft Word
Excellent communication skills

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