Regulatory Affairs Specialist at Gilead Pharmaceutical Limited

Gilead Pharmaceutical is recruiting for the following positions in Nigeria.Job Title: Regulatory Affairs SpecialistJob SummaryResponsible for assisting the team with regulatory filings as necessary to market company products.This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.Duties and ResponsibilitiesAssist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.Respond to requests from foreign government and/or distributors as neededAssist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified productsProvides regulatory direction to development project teams as a core team member; develops regulatory strategy for new productsEvaluate risk of proposed regulatory strategies; may offer solutionsReviews proposed labeling for compliance with applicable global regulationsWrites and manages the development of package insertsReviews and evaluates promotion and advertising material for compliance with applicable regulationsReviews proposed product changes for impact on regulatory status of the productCommunicates with regulatory and governmental agencies with supervision

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