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Job Ref. ID:  20325 
Job Title: Senior Specialist
Division: REGULATORY AFFAIRS
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Senior Specialist
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: The role will be responsible for the evaluation dossiers from regulatory perspective as per current guidelines and ‎company requirement for UAE and GCC countries, compilation and submission of new registration dossiers to respective countries as ‎per the registration plan, handle the queries by providing the appropriate responses, as it is required to get ‎the approvals from the health Authorities of different countries, evaluation and identification of documentation gaps during the dossier compilation ‎and communicating with the respective department to full fill requirements, follow up with the concern departments for getting the relevant documents, which ‎are required for our submission, submission UAE dossiers through online system, communication and follow-up with relevant stakeholders for fulfilling requirements ‎of new registration dossier for UAE Marketing authorization and GCC countries ‎ Provide regulatory feedback New registration dossier compilation and submission ‎as per MOH requirements. (MOH online system, CTD & eCTD)‎, and Maintain internal tracker.
Key responsibilities & Accountability: Collects & evaluates the Administrative & technical documents required for the ‎submission to different Health Authorities in different countries.‎ Prepares the Registration Dossiers for the Health Authorities in different countries ‎as per their current guidelines and the preparation of the Technical file for Drug ‎Control Laboratory.‎ Providing the responses for the queries receiving from the different Health ‎Authorities.‎ To update product specific information sheet on internal system which comprises ‎of complete approved information related to product at the time of the approval in ‎the related market. ‎ Responsible for the follow up of requested documents from different ‎departments.‎ Raising change controls for updating the technical documents (raw material ‎specifications, Finished product specifications, Formula & pack declarations ‎etc…)‎. Responsible for providing accurate information about regulations to ‎manufacturers and/or scientists.‎ Archive all the dossiers & Query reponses dispatched to different countries in data ‎management. ‎ Communicate any update in country status to regulatory manager in order to update ‎the tracker. Create and maintain check list for regulatory requirements for UAE and GCC ‎countries. Prepare monthly report for achievements. ‎ ‎ ‎
 Qualifications: 
   - Education Bachelor of Pharmacy with 5 years experience ‎
   - Experience: At least 3-5 years of related experience in Pharmaceutical field.
   - Training:
Key Competencies: Good written and verbal communication skills.‎ Time management, Leadership skills.‎ 
Technical Competencies: Excellent scientific & technical knowledge for dossier compilation in CTD and eCTD ‎format. Good knowledge of MS office (word, excel, power point), Adobe pdf, eCTD software ‎‎(PharmaReady).‎ ‎ 
 

 
 

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