Regulatory Head

Job Description : REGULATORY HEAD DUBAI a leading business conglomerate with diversified business across middles east, India and Africa in different verticals including retail, FMCG, Manufacturing, hospitality, Construction, and healthcare. For their healthcare/Pharmaceutical division they are looking to hire a Regulatory Manager/Head who will be the senior most person in the Regulatory department and will have the responsibility to manage the department from the scratch which gives the opportunity to a person to grow with the Organisation. We need someone who can work from the scratch initially and gradually develop the department in the coming years. Following are the job requirements: • The primary responsibility includes new products submissions, minor variations, post approval reporting obligations and general product life cycle management applicable to UAE and regional countries. • 4+ years of solid Regulatory affairs experience in UAE & GCC countries in a medium to large size reputable organization/s for pharmaceutical products. • In-depth understanding of regulation in UAE & GCC countries for registration of Innovator pharma product/ Generics pharma products / Herbal products GSL & nutraceuticals / Medical devices / DM approvals for food /cosmetics etc. • New Product registration, New Manufacturing Site/ MAH registration & relevant CPP/FSC legalizations experience. Preparation of regulatory dossiers & knowledge of eCTD software’s, eCTD dossier compilations. (Must have submitted a minimum of 2-3 submissions in last 1 year). • Re-Registration / Minor variations / appeal of price revision of the product. • For assigned products, Patient Package Inserts, local physicians' circulars, packaging material, Artwork, labelling approvals, analytical calculations experience. • Knowledge of analytical labs requirements for herbal and GSL products. • Knowledge of preparation of all modules in regulatory dossier including bioequivalence / stability / ICH guidelines etc. • Knowledge of DCC, HAAD Code & market access documentation. • Prepare and update week, monthly project plans, timelines of approvals and planned submissions to management. Educational Qualifications: • M Pharma / B Pharm qualification from an accredited institution / university. • GGC DRA or similar qualification would be an added advantage. • Windows MS Office/ Adobe / USDMF & EQdm / EMA & USFDA Data Mining

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