Narcotics Regulatory Affairs
Regulatory Affairs (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 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.
Roles & Responsibilities of Regulatory Affairs Specialist
- Liaison Role
- In House Documentation Role
- Country Specific Advisory Role