Regulatory Affairs(RA)

What is RA? >>Why RA?? >> Roles & responsibilities >> Career Ladder>> Skills >> Attributes

What is RA?

Regulatory Affairs (RA) is a profession within the health care industry namely, Pharmaceutical, Medical Device, Biologics, & Functional Food. RA 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 promotion of 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.
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.

Why RA??Top

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.
RA Professional 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 RATop

• Liaison Role
• In House Documentation Role
• Country Specific Advisory Role

RA Career LadderTop

• 1-3 Years of Experience  - Executive level
• 3+ years – Senior level
• Associate director
• Director
• Vice president
• President

Skills & Attributes required for making a good RATop

• Skills                                                                                                     
• Influence
• Negotiate
• Persuade
• Present
• Communicate articulately
• Listen actively
• Interpret and consolidate data
• IT literate
• Work independently and cohesively
• Accuracy
• Quality

Attributes Top

• 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
• Multi-culturally aware