Scientific Office Pharmacist - Regulatory Affairs Executive You will be responsible for the regulatory affairs function for an assigned territory of the UAE & GCC region. Relevant skills, Experience & Knowledge: Experienced in Conventional Medicines with eCTD submissions, GSL, Herbal, Medical Devices Pharmaceutical Products in MOHAP. The primary responsibility includes new product submissions, minor variations, post-approval reporting obligations, and general product life cycle management applicable to UAE and regional GCC countries. 2 to 3+ 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 etc. New Product registration, New Manufacturing Site/ MAH registration & relevant CPP/FSC legalization experience. Preparation of regulatory dossiers & knowledge of eCTD software, and eCTD dossier compilations. (Must have submitted a minimum of 2-3 submissions in the 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, labeling approvals, and analytical calculations experience. Knowledge of analytical lab 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 weekly, monthly project plans, timelines of approvals, and planned submissions to management. Educational Qualifications: The Candidate must have an Eligibility letter as a Scientific Office Pharmacist from MOH.
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 Duties & Responsibilities: Responsible to prepare and execute regulatory documentation for product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business. Develop effective communication & relationships with local regulatory bodies (UAE Ministry of Health, municipalities, DHA, HAAD, SEHA, etc) and similar regional regulatory authorities & distributors. Provide regulatory guidance & advice on local country regulatory environments, provide assessment of the impact of new and changing regulations/requirements in regional countries. Prepare (as needed) and review key application components & post meeting materials & attend meetings together and follow up with regulatory agencies. Ensure appropriate evaluation of registration requirements for new, proposed products and prepare regulatory assessment reports as needed. Interact with distributors & regulatory agencies to resolve related review questions. Provide guidance/advice on international regulatory environments, provide assessment of the impact of new and changing regulations/requirements. Review & approve all promotional material in local and regional countries and ensure MOH approval in respective countries. Preparation & maintenance of SOPs in Regulatory affairs function. Job Type: Full-time