Purpose of the Role The Regulatory Affairs Specialist supports the management of product licenses/registrations in a market or group of markets within the MENA region, from the initial submission/approval through the product life cycle.Required Competencies, Qualifications and Experience Graduate, with a Medical Professional Degree (e.g. Pharmacy, Medicine, etc.)Minimum of two years competent and consistent performance in Regulatory Affairs Function in an MNC Pharmaceutical/healthcare companyResponsibilities & Accountabilities 1) Dossier Submission & Product ApprovalIn collaboration with the line manager, compiles market specific files and documents, e.g. application forms, summary sheets, clarification letters, etc.As directed by the line manager, executes the agreed plans by coordinating the dossier submission via distributors in the respective market, as per planned timelinesIn coordination with line manager, obtains Drug Regulatory Agencies approval for new product(s)Ensures submitted product documents fully meet the local regulatory requirements for markets of responsibilitySupports follow-up with the regulatory authority during submission review and ensures all questions /requests are provided/clarified within due time to ensure timely approval of productExecutes artwork labelling projects in alignment with the concurrent regulatory applications and safety updatesCross functional collaboration and coordination with PV, Quality Assurance and Medical Affairs to ensure compliance of the labelling and artwork Regulatory ComplianceResponsible for tracking of regulatory commitmentsArchiving and maintaining regulatory related records as per local and regional standardsData entry in relevant systems and ensuring that the data is kept up to datePerforms all assigned responsibilities within assigned projects and ensure that the project is advancing as per committed timelines2) Regulatory ComplianceResponsible for tracking of regulatory commitments for the assigned filingsArchiving and maintaining regulatory related records as per local and regional standards for the assigned filingsData entry in relevant systems and ensuring that the data is kept up to date for the assigned filingsPerforms all assigned responsibilities within assigned projects and ensure that the project is advancing as per committed timelinesEnsure business compliance and implementation of and adherence to Regulatory standards.3) Regulatory Influence Understands the local regulatory guidelines and requirements for the market(s) under their responsibility4) OtherSupports the Regulatory Affairs team on administrative projectsGenerate reports, summaries of regulatory data and information for presentations or special regulatory affairs projects