Drug Regulatory Affairs
Kuwait Saudi Pharmaceutical Industries Company
مجموع سنوات الخبرة :6 years, 0 أشهر
Preparation, Compilation & Submission of Drug dossiers in CTD or NeeS format to local and foreign regulatory authorities like GCC nations: KSA, Bahrain, Qatar, UAE, Oman and Non GCC nations: Jordan, Iraq, Ethiopia etc.
New registration of drug product to procure marketing approval in different countries, submitting re-registration and minor variations documents.
Coordinate with our agents in different countries to meet national and international regulatory requirements and guidelines.
Managing Chemistry Manufacturing and Control (CMC) aspects to prepare the corresponding Quality related dossiers for registration.
Updating Information regarding domestic, GCC and International guidelines or standards needed for Drug Product registration.
Liasing with heads of different departments like QC, QA, Sales, Purchase and Production in handling technical queries and arranging Quality related technical information and documents .
Delivering lectures and conduct laboratory experiments.evaluate student performance .Planning strategies to enhance student's learning capabilities.
Analytical method development of Active Pharmaceutical Ingredients using modern analytical techniques e.g HPLC, GC, UV-Visible, FT-IR Spectroscopy, DSC, Gravimetric analysis.Wet lab analysis, analysis of raw material, in-process and finished product samples as per required standard. Instrument calibration and maintenance and ensure that laboratory records /documentation comply with cGMP.To work in compliance with company and regulatory requirements.
Synthesis of novel derivatives of terpenoids.Synthesis and isolation of binary and ternary complexes with biologically active metals and amino acids.Physicochemical studies to establish stoichiometry of complexes by potentiometric,spectrophotometric and spectroscopic studies and elemental anlalysis.Biological investigation of synthesized complexes.
• Ph.D. Chemistry -2007, Department of Chemistry, University of Rajasthan, Jaipur, India. Thesis entitled "Physicochemical and Biological Studies of Ternary Complexes of some Terpenoids and their Derivatives".
Masters in Chemistry with Specialization in Organic Chemistry
• Bachelor in Science with subjects : Botany,Zoology and Chemistry.