DRUG REGULATORY AFFAIRS

PROSPECTS & CAREERS

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.

Regulatory Affair Pathway :-

Regulatory Affairs Career Models/Pipeline

0-2 Year’s Experience 2-5 Year’s Experience 5-15 Year’s Experience

Regulatory Affairs B Pharm/ M Pharm/Graduate/post-Graduate(Chemistry)

Executive, Regulatory
Affairs Officer, RA Officer Manager Regulatory CEO, General Manager
(Production), Officer Quality Affairs, Project Manager. Regulatory Affairs,
Assurance, Quality Assurance Administrative Regulatory
manager. Affairs, Heads project,
Technical Director,
Consultants.
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.

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 below for “FREE Counseling”

Contact Details:-

Global Institute Regulatory Affairs (GIRA)

Empire Estate, Office No C5 & C6

Mumbai Pune Highway, Near Premier Ltd

Chinchwad, Pune -411019 INDIA

Phone – 020-46704472

Email – info@regulatoryinstitute.com / girapune@gmail.com

Website – www.regulatoryinstitute.com 

To know more on RA and its Career visit White Paper section on www.regulatoryinstitute.com 

Or click the below link 

http://www.regulatoryinstitute.com/whitepapers.html 

You can also Contact the following person for a FREE Counseling Section. 

Mr. Warude/Mr.Despande 

+91 9850994829/020‐46704472