Regulatory Affairs Quality Manager | Dubai

Job Position: Regulatory Affairs Quality Manager
Job Description: Dubai – Basic qualifications: Bachelor degree in pharmacy. Minimum 7 years’ experience in regulatory in pharmaceutical industry. Arabic speaker is a must. Preferred qualifications: MOH License is a plus Details: Regulatory & Government Affairs Management Responsible to create regulatory strategies and plan aggressive registration plans for new products, major changes and life cycle management. Maintain product licenses in compliance with local regulations Lead and manage the various regulatory teams at the distributors in each of the markets to ensure optimized and compliant Registration procedures. Ensure that strategic regulatory input into global regulatory strategies is provided, thus providing optimal support Develop strong partnerships with Country Managers, Medical, Marketing and Supply Chain and pro-actively ensuring Regulatory input is provided to optimize the project management and to expedite the registration of new products. Develop and execute strategies to improve (or maintain) the legislative, regulatory and recommendation environment to better achieve business goals of GSK Establish and maintain strong relationships and represent GSK with key members of federal & local governmental, regulatory bodies and Regulatory Key Opinion Leaders. Ensures Regulatory compliance of Product Artwork and all promotional materials addressed to his/her market to local legislation and code Ensure that the business is aware of possible legislation changes that could impact GSK and advise senior management on appropriate course of action Be the Claims Validation Manager of the company in his/her region of responsibility and sign off all consumer claims. Responsible for the development, leadership and performance management of the regulatory teams at our various distributors to achieve company objectives. Develop and enhance the capabilities and capacities of the distributor teams through clear direction, coaching and provid…see more details

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