Senior Regulatory Afairs Specialist
.InPharmall W.L.L
مجموع سنوات الخبرة :5 years, 5 أشهر
• Management, monitoring, and training of my direct reporters’ team of 3 regulatory affairs specialists.
• Leading the account management responsibilities of our clients (international & multinational pharmaceutical manufacturers).
• Preparation and assessment of all types of new product registration applications (NDAs, biological products, generic applications, health products, …. etc.).
• Preparation and assessment of various life-cycle management dossiers including the different types of medicines and health products variations and license renewal applications.
• Preparation and assessment of various CMC/BE studies including in-vitro, in-vivo as per the local regulations in Bahrain as well as the Gulf Health Council guidelines.
• Excellent knowledge of local (medicine new registration/variation/renewal/classification/labelling/health products), regional (GHC human data submission/stability testing/variation & renewal requirements and international guidelines like ICH, FDA guidance.
• Participating in the preparation and review of the internal SOPs, and its periodic updates and reforming.
• Preparation and review of the received applications final assessment reports for all different kinds of pharmaceutical regulatory activities.
• Helping local pharmaceutical distributors understand the best path to solve common and recurring regulatory problems.
• Full awareness about the Medicines eCTD structure and preparation best practices.
• Assessment of all types of new product registration from generic, innovative and biological products.
• Assessment of various CMC/BE studies including in-vitro, in-vivo/Variation and renewal applications of all
forms of nationally and centrally registered products/marketing authorizations.
• Excellent knowledge of local (medicine new registration/variation/renewal/classification/labelling/health
products), regional (GHC human data submission/stability testing/variation & renewal requirements and
international guidelines like ICH, FDA guidance.
• Assessment of products submitted for temporary approval, ensuring that safety, efficacy, and quality are not
compromised despite the limited information and time.
• Participating in the preparation of the periodic "PPR department" SOPs, guidance & guidelines updates.
• Preparing final assessment reports for all different kinds of Medicine and Health Products regulatory activities and issuance of various types of license approvals and database update.
• Guiding the local pharmaceutical distributors to understand the local regulations and to identify the proper path to solve common and recurring regulatory problems.
Clinical Pharmacy
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