Regulatory Affairs Specialist

Coordinates, prepares, assembles & presents the documentation required for submission to regulatory authorities in order to register the company’s new products and maintain existing registrations.Keeps abreast of current regulatory knowledge, trends, developments, legislation & guidelines.Ensures that the company strictly follows government rules and regulations.Takes part in coordinating the planning, scheduling, preparing and assembling of some regulatory projects and submissions.Prepares regulatory documentation required for registration of the company’s new products and maintenance of existing ones.Prepares regulatory documentation required for submissions of products’ variations along their life-cycle.Interfaces with other departments to provide regulatory advice and obtain the necessary documents in accordance with regulatory authorities guidelines.Submits regulatory documentation to regulatory authorities within the specified time-frame, negotiates and communicates effectively to obtain timely product approvals.Maintains regulatory files in a format consistent with requirements.Documents properly, tracks and stores regulatory documents.Acts as regulatory representative in different internal committees.Creates regulatory Standard Operating Procedures, as necessary.