Regulatory Affairs Coordinator

Delta Pharma Egypt -
Heliopolis, CairoPosted 7 years ago

112Applicants for1 open position

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Collect and coordinate information and prepare regulatory required data.
Maintain regulatory files/database and chronologies in good order.
Establish and maintain system for tracking changes in documents submitted to agencies or partners.
Maintaining database Research issues.
Coordinating CTD & e-CTD documentations.
Following and complying with all the defined internal policies and procedures of working.
Gathering, organizing, managing and collating information in a variety of formats.
Coordination and set up of all project related files, tracking of all related paperwork and filing.
Using a variety of specialist computer application.

Medical background degree or equivalent professional qualification.
2 years relevant experience within the regulatory affairs discipline.
Relevant product and industry knowledge.
0-2 years of experience in similar position.
Computer skills, Negotiation & Communication skills.
Good Command of English Language.
Organization skills and high accuracy in documentation.
High sense of urgency.
Knowledge of new decrees & guidelines.
Time Management.
Awareness and adherence to company internal SOPs & compliance standards promptness in deliverable and in response to authorities requirements.
Understand the link between own priorities and organization ambition.
CTD & e-CTD