Pharmaceutical Regulatory Affairs

PROGRAM INTRODUCTION

The M.Pharm in Pharmaceutical Regulatory Affairs is a first time course offering in India introduced by JSS University. It aims to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. Students are encouraged to enhance their knowledge of regulatory and compliance issues and to explore careers in these exciting times. The ever-changing laws and regulations are driving demand for pharmaceutical regulatory affairs professionals, who can help companies effectively bring medical products to market.

MERITS

Scope

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (R&D) efforts of the company to the market. The regulatory department works with a focus to get products to the market with a commercially viable label, in the least possible time and expense. In view of the increasing global competitiveness among pharmaceutical companies, the key to success lies in obtaining timely marketing approval from the Regulatory agencies of the region where the drug is to be sold. Various government agencies are involved in regulating drugs within their market, namely, USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada. Regulatory Science is becoming increasingly influential in the overall drug development process and is increasingly populated by highly trained scientists and medical professionals.

“Drug Development is long, risky, expensive, and those characteristics mean regulatory affairs personnel have their work cut out for them”

Objectives

  • To provide quality inputs in the area of Pharmaceutical Regulatory Affairs
  • To develop documentation / research writing expertise in the field of Pharmaceutical Regulatory Affairs
  • To make available a pool of competent professionals in the area of Pharmaceutical Regulatory Affairs

Career Opportunities

PRA professionals can be employed as

  • Regulatory Affairs Consultants
  • Regulatory Affairs Associates
  • Regulatory Affairs Assistants / Specialist
  • Regulatory Affairs Head / Director
  • Regulatory Administrator
  • Regulatory Compliance Manager
  • Medical Information Associates
  • Drug Inspector / Drug Controller
  • Drug Safety Specialist / Regulatory Food Safety Scientist
  • Quality Operations / Quality Control / Quality Assurance