Pharmaceutical Regulatory

Affairs
Chapter 1: Introduction to RA

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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.

Regulatory Affairs is a unique combination of science and management to

achieve a commercially important goal within a drug-development organization. 

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.
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Quality Excellence and Research Center Pune
Quality Excellence and Research Center Pune
Quality Excellence and Research Center Pune
Quality Excellence and Research Center Pune
Quality Excellence and Research Center Pune
 SCOPE OF REGULATORY AFFAIRS

Regulatory affairs professionals are employed in industry, government regulatory

authorities and academics. The wide range of regulatory professionals includes in
these areas:
• Pharmaceuticals
• Medical devices
• In vitro diagnostics
• Biologics and biotechnology
• Nutritional Products
• Cosmetics
• Veterinary Products

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Quality Excellence and Research Center Pune
 1.Keeping track of the ever-changing legislation in all the regions in which
a company wishes to distribute its products.

 2.Advising on legal and scientific restraints and requirements.

 3.Collecting, collating and evaluating scientific data.

 4.Presenting registration documents to regulatory agencies and carrying

out any subsequent negotiations necessary to obtain or maintain marketing
authorization for the products concerned.

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 5.Giving strategic and technical advice at the highest level in their
companies, making an important contribution both commercially and
scientifically to the success of a development programme and the
company as a whole.
 6.Helping the company avoid problems caused by badly kept records,
inappropriate scientific thinking or poor presentation of data.

 7. Preparation of organized and Ensure adherence and compliance with all

the applicable CGMP, ICH, GCP, GLP guidelines regulations and laws.

 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.

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Quality Excellence and Research Center Pune
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.
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 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.

Quality Excellence and Research Center Pune

Quality Excellence and Research Center Pune