Regulatory Affairs (RA) is an upcoming profession within the pharmaceutical sector. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.

What are the responsibilities?
In Industry:
1. Interact with all departments of the company and based on this cooperation
2. Prepare a variety of documents necessary for research, development and production of drugs/medical devices.
3. Frequent interaction with government is necessary to obtain regulatory approval for conducting clinical studies and for production of therapeutics

In Government:
1. Assure that industry complies with regulations.
2. Reviews documents submitted by industry and
3. Releases permission for conducting clinical studies or for product manufacturing and distribution, based on regulatory and scientific merits.

What is it all about
Pharma is a highly regulated industry the world over and professionals, who can manage regulatory affairs, are in high demand.
Selling drugs is not like selling anything else, when we sell drugs we need to be confident that -
  • They do what they claim to do
  • They have been through a tough testing process to get from the lab to the market
  • The side effects are well documented

This is where the regulatory affairs comes in.

What you will need to become a RA professional
  • A good background knowledge of the pharmaceuticals and medical environment
  • A meticulous approach to work
  • Attention to detail.
  • Academic Qualification in Regulatory Affairs

You can expect to work in a multidisciplinary workplace where scientists and medics will come from very different backgrounds. Excellent written and verbal communication skills are a must as is the ability to work effectively under pressure

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Institutes offering this course in India
In India, so far only two universities:

  • Guru Jambeshwar University, Haryana
  • Manipal College of Pharmaceutical Sciences, Manipal

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The curriculum
  • It deals with the USFDA and EUDRA guidelines concerning filing for New Drug Applications and Abbreviated New Drug Applications;
  • FDA, International Conference on Harmonisation (ICH), EUDRA and Pharmaceutical Inspection Convention (PIC) guidelines for various operational activities;
  • Intellectual Property Rights such as Patents, Copy Rights, Trademarks; etc for patenting


The Future
Regulatory affairs position is in highest demand and fastest growing according to the findings from a recent survey on employment trends in the clinical trials industry from CenterWatch4, the reasons being the lack of candidates who wish to make their career in this field and increasing turnover of the pharmaceutical industries. Pharmaceutical

Regulatory affairs is a vast area, which cannot be taught just with the help of books or the course materials. The issues related to the field are often updated so the professionals find it challenging to keep abreast with the recent modifications and inclusions.

Queries are welcome.