REGULATORY AFFAIRS PROFESSION AND CAREER
RegulatoryAffairs (RA) is a profession within the health care industry namely, Pharmaceutical, Medical Device, Biologics, & Functional Food. Regulatory Affairs can be defined as It means government affairs Their main role is to comply with Safety & Efficacy of the products as per regulation laid down by the government. They advise companies on all regulatory aspects and laws pertaining to their business such as the promotion of the prescription drug.
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..
RAprofession 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.
Why Regulatory Affairs as a Career??
The Pharmaceutical sector has been ever growing and with globalization the race to lead to be first is no more restricted by boundaries, companies need to dominate on a global level to stay on top. As a result of this competitiveness companies success lies in the “time taken” by the product to reach the market.
To
achieve this Regulatory Affairs of a company must be conducted appropriately
and systematically as this activity is of considerable economic importance for
the company.
On an average it takes 15-20 years for a new drug development, and it cost around $800 million. With such an expensive and time consuming activity companies cannot afford a single day delay in getting the product to the market.
RAProfessional play the very important role in getting the product to market, improper data reporting can delay evaluation of a positive marketing authorization. They play a crucial role right from the beginning of product development to post marketing authorization. An early correction in product development can save the company lot of time and money.
In appropriate labeling can call for an early recall of the product disturbing the company’s image and public confidence. Improper documentation can mean a product withdrawal, denial of MA.
A good RA professional will have a sound approach and plan his work systematically, he will co-ordinate effectively with the scientist and the regulatory agencies, he will foresight the possible risk and problems and communicate the same to the development team to prevent any future looses.
The
best regulatory people work hand in-hand with marketing and R&D to develop
innovative, risk-taking development plans that take advantage of new
technological and regulatory developments to accelerate time to market An RA
professional is the first point of contact between the regulatory agencies and
the companies.
Roles & Responsibilities of Regulatory Affairs Specialist
·
Liaison
Role
·
In
House Documentation Role
·
Country
Specific Advisory Role
Regulatory Affairs Career Ladder
·
1-3
Years of Experience - Executive level
·
3+
years – Senior level
·
Associate
director
·
Director
·
Vice
president
·
President
Skills & Attributes required for
making a good Regulatory Affairs officer
·
Skills
·
Influence
·
Negotiate
·
Persuade
·
Present
·
Communicate
articulately
·
Listen
actively
·
Interpret
and consolidate data
·
IT
literate
·
Work
independently and cohesively
·
Accuracy
·
Quality
Attributes Required for Regulatory
Affairs Specialist
·
Team
player (cross-functionally)
·
Quality/accuracy
focused
·
Calm
under pressure
·
Interactive
·
Ambassador
(promote regulatory affairs)
·
Positive
·
Open
to change
·
Flexible
·
Adaptable
·
Self
motivated / driven
·
Ethical
·
Robust
·
Willing
to learn
·
Enthusiastic
·
Assertive
and confident
· Respond effectively to challenges of opinion
Sense of humour
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