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.
Bachelor of Pharmacy with 5 years experience
At least 3-5 years of related experience in Pharmaceutical field.
Good written and verbal communication skills.
Time management, Leadership skills.
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).