Gowthami V.

About Gowthami V.

Myself, Miss. Gowthami V, Presently worked with Paraxel International PVT Ltd– Bangalore as Associate in Regulatory Affairs, having one year experience in the areas of preparation, Review of documents and Compilation of Clinical Trails Applications.Previously worked in Apotex Research Private Limited – Bangalore, as Assistant analyst having One year six months experience in the areas of Quality control with respect to regulatory affairs. Creating submission plan and uploading of documents under the various modules 1-5 in the eCTD software, Maintenance of submission in eCTD as per life cycle of the product and also responsible for reviewing of analytical data of in-process analysis, finished product analysis and Stability data for submission batches in which coordinating on regular basis with Regulatory Department.

Experience

1. Analyst

   Apotex India

   Oct 2015 — Present · IN

   Previously worked as assistant analyst having one year six months experience in the areas of Quality control with respect to regulatory affairs in which Responsible for compilation and review of dossier for a product for the regulated markets and customers.Responsible for Review of documents that are required for the submission such as PDR,MFR,MPR, BMR and BPR, analytical method validations, process validations, stability protocols, specifications and test methods (RM, FM and PM, IP) etc.Synchronize with the various departments (F R&D and QC, QA, packaging, Purchase, Production, medical for collection of technical and medical data and Clinical trail related documents from clinical teams,) for the compilation of dossiers as per the guidelines.Dossier review compilation for Eu country specific requirements (U.K, U.S, Germany etc).Compile CMC-Sections, DMF, API, pharmaceutical intermediates for finished dosages, pharmaceutical formulation in CTD format to FDACompilation of documents for post approval variations, annual reports and renewal of documents.Coordinate and perform the lifecycle management processes with regard to pharmaceutical quality documentation(change control procedures, prepare and submit variations, site transfers etc. with regard to strategy and content)Expert in planning, management and delivery of projects where stake is high and time is crucial.Expert in e-CTD submission, validation with submission via gateway like CESP and portal submisisons (MHRA) Managing the global submissions and responsible for the new product launch activitiesPreparation of dossier according to the Module 1 and Module 2 (Quality) and Module 3 as in eCTD/ NeeS as per EU / ANDA requirements or country specific requirementsReview of all stratified samples according to specificationsReview of all documents according to specification and supporting to regulatory submissionsWorked on empower and Lims software. and Reviewed all documents in Lims software.

Education

• Rajiv Gandhi University of Health Sciences

  Pceutical Chemistry

  2013 — 2015

Skills

• Harrdwrki
• Clinical Trials
• Research
• Teaching
• Analysis
• Sports
• Ich-Gcp
• Pharmacovigilance
• Public Speaking
• Medicinal Chemistry
• Regulatory Affiars
• Analytical Skills
• Clinical Research
• Microsoft Office
• Training
• Strategic Planning
• Chemistry
• Microsoft Word
• Analytical Chemistry
• Powerpoint