Professional Documents
Culture Documents
Pharmaceutical: Regulatory
Pharmaceutical: Regulatory
Affairs
BPH 425
Chapter 1: Introduction to RA
Regulatory affairs is a profession developed from the intention of governments to
protect public health by controlling the safety and efficacy of products
including pharmaceuticals, veterinary medicines, medical devices, cosmetics so that that
supplied products make a worthwhile contribution to public health and welfare.
The drug development process is a lengthy, complex and extremely costly albeit
necessary process. Regulatory Affairs plays a crucial role in the pharmaceutical
industry and is involved in all stages of drug development and also after drug
approval and marketing.
It gives strategic and technical advice at the highest level in their companies, right
from the beginning of the development of a product, making an important
contribution both commercially and scientifically to the success of a development
program and the company as a whole.
SCOPE OF REGULATORY AFFAIRS
8. A regulatory affair plays a crucial role in the industry and is involved in all
stages of drug development and also after drug approval and marketing.
Job description of an RA executive:
Assisting in Responding Queries for various regulatory authorities.
Analyzing and arranging dossier in CTD/eCTD formats for regulatory submissions.
Up to date maintenance of Documentation Data base available with RA.
Coordination with cross functional departments like QA, QC, Production, Warehouse,
Distribution and Marketing for dossier preparation, Post approval supplement filling
and respond to queries.
Routine Interaction with QA-documentation for updating Master Files.
Review of Artworks (Labels and Package Insert).
Good knowledge of Module 3.
Knowledge of ICH Guidelines.
Review and approval of QC spec, STP, method validation inline with pharmacopoeia.
Review and approval of R&D/ Products document in line with pharmacopoeia
and regulatory requirements
Coordinate with cross functional departments such as Operations, QA, QC,
Engineering etc, and support to regulatory Preparation and review of Master
safety Data sheet, TSE & BSE documents
Regulatory Compliance, for change control activities monitoring the impact of
changes in regulatory submissions.
Assess and review documentation to ensure compliance with product licences.
Monitoring the progress of registration submissions, responding to queries and
ensuring that registration approvals are granted without undue delays.