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Drug Regulatory Affairs

Drug Regulatory Affairs deals with the areas of drug approval process and different regulatory protocols required by regulatory bodies. It covers all the aspects of documentation and marketing of drugs in a legalized form. Since the pharmaceutical industry is highly regulated, regulatory bodies have framed laws and guidelines of quality, efficacy and safety of pharmaceutical products. Regulatory Affairs (RA) professionals play critical roles in pharmaceutical industry because it is concerned about the healthcare product lifecycle; it provides strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.
Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and teamwork, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.


Drug regulatory affairs objectives in industry


  • To ensure that all medicines manufacturing, importation, exportation, wholesale and distribution establishments are licensed. Activities and premises must comply with Current Good Manufacturing Practices (CGMP) and Good Distribution Practice requirements
  • To regularly inspect and control the informal market, including e-commerce, to prevent illegal trade of medicines
  • Monitors advertising and promotion of medicines, and provide independent information on their rational use to the public and professionals
  • To participate in sub-regional and regional regulatory networks and international meetings of drug regulatory authorities to discuss issues of mutual interest and concern, facilitate timely exchange of information and promote collaboration
  • To monitor and evaluate performance to assess if perceived regulatory objectives have been met, to identify weaknesses and take corrective action

Scope of drug regulatory affairs


  • In conducting clinical trials & their filing to regulatory bodies
  • In product management team for registration of drugs
  • In writing leaflets and labels of products
  • In R&D teams for patent registration

Eligibility


The minimum eligibility criteria for Advanced training courses in Pharmacovigilance and Regulatory affairs would include either of the following:

  • Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc.
  • Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc.
  • Any degree in Pharmacy / Pharmaceutical Sciences
  • Any degree in Chemistry / Biostatistics / Bioinformatics
  • Any degree in Nursing / Allied Health
  • Students pursuing graduation / post-graduation are also eligible to apply.
  • These courses can be done by the working professionals also, as they don’t have to quite their job, they can go for e-learning training program.