What is Regulatory Affairs?
Regulatory Affairs (RA) is an upcoming profession within the biomedical / health products 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.
In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.
They need to keep a track on ever changing legislation in all countries where the companies is looking to market their product.
RA profession is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing. Their advice at all stages both in terms of legal and technical requirements and restrains help companies save a lot of time and money in developing the product and marketing the same.
They have a major contribution in company’s success both Commercially and Scientifically.
Careers in Regulatory Affairs:-
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 regulatory affairs come in.
“Regulatory Affairs Professional is the key link to distributing your drugs to world region.”
The Indian Pharmaceutical industry is one of the fastest growing industry in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally.
With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory law, policies and procedures for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.
The increasing graph of the global companies’ setup in India demands the trained and skilled professional on a Handsome Salary, looking back for past few years rise in salary is multiplying.
There is a widening gap of rising demand and too few skilled human resource, this has seen a 50 % zoom on average in salaries for skilled manpower specifically in CRO sector alone. On an average there has been over 30% rises in salaries in Pharmaceutical Sector.
Research & Development activity in the Pharma sector is seeing a rapid growth and this growth is only poised to increase the need for skilled manpower and higher pay scale to retain the skilled.
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.
It is not easy for any Science Graduate to get a good salary hike in the pharmaceutical/chemical industry without having the appropriate qualification/knowledge. However, when a person spends at least 2-3 years in the same field, he/she can master the job. However, to be a project leader or to get into the higher ranks of the organization, a person needs to be aaware of the changing trends of the industry. This is where Regulatory Affairs plays an important role. With environmental issues cropping up each day and the stringent measures adopted by Environmental Protection agencies, FAO and the WHO and other NGOs, it is very important for an organization to have an individual who can flexibly handle and understand all the critical procedures of the company and can help in the amooth functioning of the company.
For all Life Science Graduates or Basic Science Graduates working in Pharmaceuticals /Agrochemicals companies, can enhance their knowledge and have an edge over your peers by having any additional Diploma or Certificate courses.
Some of the institutes offering courses on the same lines through Part-time for working professionals or Through distance Education are:
Institute of Pharmaceutical Management - (IPM), Dombivli.
Global Institute of Regulatory Affairs, Pune.
Bioinformatics Institute of India, Noida.
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