REGULATORY AFFAIRS PROFESSIONAL

Highly educated professional with strong background in pharmaceutical science, seeking a suitable and stable position leading towards a successful career in growth oriented organization offering ample opportunities for growth, advancements and achievements ,utilizing all my technical qualifications and capabilities in overall success of the company and that offers an opportunity to enhance my professional growth.

Profile Overview

A dynamic professional with exceptional skills on awareness and understanding of technical details

Excellent ability to interact with people of diverse cultural backgrounds and technical levels

Knowledgeable in organizing pharmaceutical records and departments like Quality Control, Quality Assurance in organization

High on people skills with demonstrated leadership skills, strong on managing through influence

Deftness in understanding needs of cross functional teams and translating them into desired results

Exposure to Validation and the Regulatory Affairs, Contemporary Concept in Validation, Good Manufacturing Practices in the Pharmaceutical Industry

Experience in Production & Manufacturing & Quality Control Departments

Technical Skills: Microsoft Word, Power Point, and Excel with very good keyboard skills

Educational Credentials

University Of Greenwich, London, UK – 2010 Masters of Science in Pharmaceutics

Subjects: Research methods and skills, Separation science, Clinical trials, Pharmacovigilance, Statistics and Computing

Pharmaceutical technology, Pharmaceutical Instrumentation, Design, Discovery & Development of pharmaceuticals, Development, Manufacturing and Regulation of Medicine.

Project: Separation of enantiomers in a racemic mixture by NMR & HPLC using Chiral Shift Reagents

Dr D.Y. Patil College of Pharmacy, Pune University, India - 2008 Bachelors of Pharmacy

Subjects: Dispensing of pharmacy, Drug store and business management, Pharmaceutics, Biostatics and computer application, Pharmaceutical analysis, Pharmacology, Pharmaceutical medicinal chemistry, Biotechnology, Pharmaceutical engineering, Microbiology and Immunology

Professional Experience

Accountabilities & Acquaintances

Manage and facilitate all registration related activities – review and assess Deviations, including evaluation, tracking, follow-up, and reporting /trending to ensure product quality and process control

Complete forms and requests originating from government agencies

Work Precisely according to procedures, rules and regulations

Documentation Skill and way of presentation

Established and Reviewed QA procedures, product and process development activities,

Check & Update of Standard Operating Procedures, Formula Records, Validation Protocols and Reports whenever necessary as per the update licensing and collect information on regulation instructions

Performed reviews of manufacturing, support documentation and records to plan the achievements within the timely constraints

Personal Details

Date of Birth 1st June, 1986

Nationality Indian

Gender Male

Passport Number G5986895

Work Authorization Post Studies Work (PSW) Visa for UK

Languages Known English, Hindi & Marathi

References Available Upon Request