Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science companies ensure that their companies comply with all of the regulations and laws concerning their business. Regulatory Affairs is a unique mixture of science and management to achieve a commercially important goal within a drug-development organization. Regulatory Affairs takes care of Development plan, supervising-writing / reviewing and assembling and submission management. They give 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 programme and the company as a whole.
Jobs in pharma regulatory affairs require a background in the applicable industry, business knowledge, great oral and written communication, good attention to detail and strong IT skills.
Jobs in pharma regulatory affairs require a background in the applicable industry, business knowledge, great oral and written communication, good attention to detail and strong IT skills. A good Regulatory Affairs professional will have a ‘right first time’ approach and will play a very important part in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximize the cost-effective use of the company’s resources. The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. Officials respond much better to a company whose representatives are scientifically accurate and knowledgeable than to one in which these qualities are absent.
Food & Drug Administration is main regulatory body which regulates and implements rules to pharma industries. It has many branches and sub branches in different parts of the world. There are various regulatory bodies such as TGA for Australia, HPB for Canada, USFDA for USA, FIDMD for Germany, CDSCO for India and many more.
As globalization of world, geographical barriers have become obsolete. Any company from any part of the world can be globalized itself and it can carry out its business in any country. And Pharma industries learned faster about global needs and carried its business across different companies. We know that many pharma companies doing business in millions and billions in the world. So for carrying business in different countries, Pharma companies have to fulfill lot of documentation and technical needs of those countries regulatory bodies.
Approval from regulatory bodies is most essential and it can surely change huge margin of turnover for that company. Apart from this, Pharma companies have to keep updated on top of the latest developments within the industry to writing product labels and patent information. As well as collecting and collating large amounts of information and preparing licensing submissions, liaising with doctors and scientists, conducting clinical trials and negotiating with regulatory authorities. For this purpose nowadays all pharma companies developed separate division like production, QC, QA and that is DRUG REGULATORY AFFAIRS (DRA).
We provide Pharma Regulatory Affairs course in two levels as Professional Designation for undergraduate students and Advance PG Program for Graduated Students. The details of the courses are as below:
So from the above, we can conclude that requirement of DRA professionals is today’s most necessity of Pharma Industries and because of Globalization of the world, it is most needed area for all national & international pharma companies. Pursuing courses like Pharma regulatory affairs surely opens big opportunities at your doorstep.
The below statistical graph predicts an average data of placements in regulatory affairs over a year globally.