Drug Regulatory Affairs – Careers & Prospects – Pharmaceutical Industry
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
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 :-
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.
Global Institute of Regulatory Affairs (GIRA)
GIRA has developed a Post Graduate Diploma (Sunday batches) and Advanced P.G. Diploma in RA (Full Time) which will surely help the professionals as the program address regulatory Affairs within each category of regulatory agencies of various country, Drugs and Medical devices.
This Program will be a complement to those who carrying Science, Pharmacy and Health related degrees, there are many rewarding career opportunities with regulatory affairs for individuals with a variety of backgrounds.
The courses has been developed, under the guidance of Industry and Government Experts, to provide broad regulatory foundations, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry.
Courses are taught by experienced regulatory professionals currently working in device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse their courses with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs.
GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” – providing intelligent regulatory solutions since last 20 years
Please contact GIRA for “FREE Counseling & Course Prospectus”
To know more on RA and its Career visit White Paper section on
Global Institute of Regulatory Affairs
www.regulatoryinstitute.com
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Global Institute of Regulatory Affairs – www.regulatoryinstitute.com