Vikar Ansari

About Vikar Ansari

Optimist, Curious, Serious, eager to learn new approch.

Experience

1. Lead Associate Drug Regulatory Affairs

   Genpact

   May 2021 — Present · Mumbai, IN

   Working in Global Drug Regulatory Affairs- CMC Authoring for Annual report, Renewals of product, Post approval for pharmaceutical product- well knowledge for U.S, Canada and Europe countries- Well experience to compile and author Distribution data for U.S, Europe, UK, Japan and international countries- Well experience to haldling SAP/BOBJ Software for Analysis of distribution data- Experienced to author document in ViVa Vault- As Annual Report submission planner for U.S country- Expert in submission of documents- Preparation and Authoring Module 1 to Module 3- Preparation and Authoring CMC document- Preparation CES documents, Authoring Periodic Safety Update Report- Preparation Clinical expert Statement various US country- Preparation of Clinical Declaration document for various country- Working on Biological CMC Products- Working as CMC scientist for client for U.S- Annual Report filing for NDA And ANDA- Prepare a dossier for U.S country- Prepare Annual report for different country- Work as Annual Report Submission Planner- Prepare Annual planning report- Prepare Core Submission Plan- Prepare Annual Report Alert Notice- Prepare Draft Submission for Annual Report- prepare ANDA filling for U.S.F.D.A- Identify changes and variation for post approval market- Software Handling Knowledge for ECTD Preparation- ViVa Vault, RIMS, RADR, RSDM, Reliant, SPT, CRI, Cognos, SPARS, APPIAN, SharePoint, EZone, Aggregate Report Filing (PSUR), Microsoft Excel, Word, PowerPoint.

Education

• Dr. Babasaheb Ambedkar Marathwada University, Aurangabad

  Post Graduate Diploma in D.M.L.T

  2017 — 2018

• North Maharashtra University

  Doctor of Philosophy - PhD

  2023 — 2026

• North Maharashtra University

  MASTER OF PHARMACY

  2014 — 2016

• North Maharashtra University

  BACHELOR'S OF PHARMACY

  2011 — 2014

• University of Mumbai

  DIPLOMA IN PHARMACY

  2009 — 2011

• University of Pune

  Master of Business Administration (M.B.A.)

  2014 — 2016

Skills

• Microsoft Office
• Administration
• Clinical Research
• Powerpoint
• Microsoft Excel
• Pharmaceutical Sales
• Regulatory Affairs
• Ph Meter
• Clinical Trials
• Teamwork
• Microsoft Word
• Management
• Microwave Synthesis
• Market Research
• Formulation
• Research
• Research and Developement
• Biotechnology
• C++
• Pharmacovigilance
• Gmp
• Hospitals
• Regulatory Requirements
• Pharmaceutical Industry
• Sop
• Fda
• Solvent Extraction
• Calorimetry
• Validation
• Ftir
• Pharmaceutics
• C
• Healthcare
• Pharmacology
• Hplc
• Photoshop
• Life Sciences
• Gcp
• Dissolution Testing
• Regulatory Submissions