Vaiharthanan Sethunathan

Documenting & Reviewing SOP for clinical trial site initiation according to GCP guidelines.

* Performed as Wholesale Pharmacist, where I was responsible for Psychotropic and Narcotic Medicines Registration with Regulatory Authority and Supplies of medicines to Ministry of Health. * o Reviewed and compiled the eCTD pharmaceutical product dossiers and submitted to the relevant regulatory authority for approval and obtained full registration for about 70 product dossiers. o Supervised all supply chain procedures, cold chain management, inventory and stock control procedures, and warehouse. o Successfully completed all the assigned tender orders and achieved tender sales turnover of more than USD 800,000 for the year 2023 and received incentives as part of sales commission. o Checked contents of product labels & patient Information leaflets regarding to local authority (NMRA), BNF, ICH, EMA and US FDA guidelines. o Organized and pre-planned the regulatory product approval pathways of imported medicines, medical devices, neutraceuticals and cosmetics.

# Reviewed Drug dossiers to submit and obtain registration with Sri Lankan Regulatory Authority (NMRA) in accordance with SL regulatory guidelines, FDA guidelines, Pharmacopeia and other relevant guidelines. # Engaged in registration of Ayurvedic products, Natural health products and Dietary supplements. # Provided education and training to marketing team regarding pharmacology of drugs. # Inspected visual quality of the product before market release.

Engaged in Island wide Pharmacovigilance survey of Anti- TB drugs

Completed with BDP proposal at London School of Commerce, Colombo, Sri Lanka