Experience

FLAVINE PHARMA INDIA

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Manager

  • Mar 2016 - Present

  • An effective communicator with good relationship management skills and strong analytical, presentation. problem solving & organizational abilities. • A competent professional with 10 years of experience in: Dossier Preparation (BA/BE studies) Regulatory Query Handling Report Preparation Data Collection & Analysis Bio-analysis/ Coordination • Single point of contact between suppliers of API across globe and customers (India based) for technical support. • End to end technical aspect handling from project initiation till approval grant aligning with respective API manufacturers. • Co-ordinating for timely deficiency solving and subsequent submission of response by customers for all health authorities. • Prepare supporting documents for new registration. • Generating and reviewing BA/BE reports as per ICH E3 guidelines for submission to Regulatory Agencies of USA, Europe, India, Canada, Australia, etc. in eCTD format • Support product and facility approvals during regulatory inspections and by addressing regulatory queries received on filed BA/BE studies. • Aware of guidance documents of Regulatory Agencies (e.g. USFDA, Health Canada, EMA, TGA Australia) for conducting bioequivalence studies • As a part of project management team, key milestone/mapping, incorporating changes wherever applicable and updating department related project report. • Coordinates effectively with stakeholders for timely delivery of assigned projects. • Aware of Quality Control (QC) unit processes as assisted in various QC activities and audits conducted by various Regulatory Agencies • Conversant with Investigator’s Brochure, GLP, GCP concepts & OECD guidelines Show less



Sun Pharmaceutical Pvt Ltd (formerly known as Ranbaxy Labs Limited)

• Senior Research Scientist

  • Jan 2012 - Feb 2016

  • Managing the activities of Query group • Coordinate for providing inputs for the suitability of bio-study data as per Regulatory Requirements for filing of product dossiers. • Generating and reviewing BA/BE reports as per ICH E3 guidelines for submission to Regulatory Agencies of USA, Europe, India, Canada, Australia, etc. in eCTD format • Provide cogent and logical responses/clarifications to observations given by Regulatory Agencies (USFDA, EMEA, WHO, ANVISA, Health Canada and TGA Australia) during their inspection/audit of bioequivalence study/site • Deliver quarterly presentations to relevant teams in the department regarding regulatory requirements based on queries received. • Address concerns raised by BE assessors/consultants of Reviewing Agencies/Product Partners regarding bioequivalence studies for product approvals • Working on Anti-infective /Anti-allergic /Antiviral /Antidiabetic /Antibacterial / Antihypertensive Drugs • Review bioavailability/bioequivalence study protocols, Standard Operating Procedure (SOP), method validation, analytical and bioequivalence study report with respect to queries received from regulatory Agency • Review and submit supporting documents (Bioequivalence Summaries, Bioequivalence Trial Information Form, Office of Generic Drugs – Study Summary Tables & Clinical Summary) to Regulatory Agencies along with bioequivalence study report Show less



Ranbaxy

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist

  • Jun 2008 - Dec 2011

  Preparation and release of BA/BE reports for various regulatory agenciesWoked as analyst in Bioanalytical department

• Research Associate

  • Jun 2006 - Jun 2008

  Development and validation of Bioanalytical methods on LC-MS/MS for generics and NCE's