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 are knowing that many pharma companies doing business in millions and billions in the world. So for carrying business in different countries, pharma companies have to fulfil lot of documentation and technical needs of that 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 now a days all pharma companies developed saprate division like production, QC, QA and that is DRUG REGULATORY AFFAIRS (DRA).
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.
So from above we can conclude that require of DRA professionals is todays most necessity of Pharma Industries. And because of Globalization of the world, it is most needed area for all national & international pharma companies.
Pursuing full time course like M.S in regulatory affairs surely opens big opportunites at your doorstep.
FIND MORE ON DRA:
INVOLVEMENT OF HEALTHCARE REGULATORY AFFAIR PROFESSIONAL IN OVERSEAS REGISTRATION PROCESS