Summary
Overview
Work History
Education
Skills
Timeline
Generic
Satyam  Pateriya

Satyam Pateriya

Pharmaceutical Regulatory Affairs (Research & Development)
Bangalore

Summary

A competent professional and qualified Post-Graduate in ‘Pharmaceutical Regulatory Affairs (Research and Development)’ with 13 years of experience in Industrial Pharmacist in organizations of high repute. Work experience in diversified environment and culture while working with people from various geographies.


Overview

13
13
years of professional experience
6
6
years of post-secondary education

Work History

Senior Manager - Pharmaceutical Regulatory Affairs

Elanco Innovation and Alliance Centre India
Bangalore
01.2020 - Current
  • Participate in research for the development of new drugs by reviewing the research documents, preparing them as per the Government Health authority guidelines and submitting for the new drug marketing authorization.
  • Currently working on various activities of drug development and marketing authorization applications with Health Canada.
  • Support the Chemistry, Manufacturing and Control (CMC) of drug development including the test new drug products for stability and shelf life.
  • Control the quality of drug products during production to ensure that they meet standards of potency, purity, uniformity, stability and safety.
  • Develop information materials concerning the uses, properties and risks of particular drugs.
  • Evaluate labelling, packaging and advertising of drug products.
  • Working in close collaboration with the Canada counterparts of my organization (Elanco Canada Limited, Mississauga).

Associate Manager - Pharmaceutical Project Manager

AstraZeneca Ltd.
Bangalore
11.2017 - 01.2020

Managing the entire life cycle of drug development and submitting the application for the Marketing authorization/Licence to various Govt. health authorities, majorly USFDA, EMA, Health Canada, SwissMedic.

Associate Manager-Pharmaceutical CMC

Novartis Healthcare Ltd.
Hyderabad
08.2013 - 11.2017
  • Participate in research for the development of new drugs by providing the current guidelines and regulations for performing the research activities for the drug development.
  • Control the quality of drug products during production to ensure that they meet standards of potency, purity, uniformity, stability and safety

Executive-Pharma Regulatory Affairs

Agila Speciality Ltd. (Now Mylan Inc.)
Bangalore
06.2012 - 08.2013
  • Develop information materials concerning the uses, properties and risks of particular drugs
  • Evaluate labelling, packaging and advertising of drug products

Junior Associate Manager-DRA R&D

Gland Pharma Ltd.,
Hyderabad
08.2011 - 05.2012
  • Develop information materials concerning the uses, properties and risks of particular drugs
  • Evaluate labelling, packaging and advertising of drug products

Executive-Pharmaceutical RA

Pharma Leaf India
Bangalore
08.2010 - 08.2011
  • Coordinate clinical investigations of new drugs
  • Control the quality of drug products during production to ensure that they meet standards of potency, purity, uniformity, stability and safety

Trainee-RA R&D

Zydus Research Centre, Ahmedabad
Ahmedabad
10.2009 - 04.2010
  • Coordinate clinical investigations of new drugs
  • Control the quality of drug products during production to ensure that they meet standards of potency, purity, uniformity, stability and safety

Education

Master of Science - Pharmaceutical Regulatory Affairs

Manipal University
Manipal, India
07.2008 - 07.2010

Bachelor of Pharmacy - Pharmaceutical Sciences

Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bhopal, India
07.2004 - 07.2008

Skills

    Research and Development as Industrial Pharmacist

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Timeline

Senior Manager - Pharmaceutical Regulatory Affairs

Elanco Innovation and Alliance Centre India
01.2020 - Current

Associate Manager - Pharmaceutical Project Manager

AstraZeneca Ltd.
11.2017 - 01.2020

Associate Manager-Pharmaceutical CMC

Novartis Healthcare Ltd.
08.2013 - 11.2017

Executive-Pharma Regulatory Affairs

Agila Speciality Ltd. (Now Mylan Inc.)
06.2012 - 08.2013

Junior Associate Manager-DRA R&D

Gland Pharma Ltd.,
08.2011 - 05.2012

Executive-Pharmaceutical RA

Pharma Leaf India
08.2010 - 08.2011

Trainee-RA R&D

Zydus Research Centre, Ahmedabad
10.2009 - 04.2010

Master of Science - Pharmaceutical Regulatory Affairs

Manipal University
07.2008 - 07.2010

Bachelor of Pharmacy - Pharmaceutical Sciences

Rajiv Gandhi Prodyogiki Vishwavidyalaya
07.2004 - 07.2008
Satyam PateriyaPharmaceutical Regulatory Affairs (Research & Development)