The Chat Lounge

FloraSeed · Joined: 22 Nov 2007 Posts: 1 Reputation: 0

The field of Regulatory affairs is concerned with the national and international framework of laws, regulations, guidelines and principles governing finished formulations of prescription medicines, OTC medicines and food supplements. Regulatory affairs also involve interpreting and applying these statutory and other requirements for the company.
The pharmaceutical industry is the most regulated of all industries. The obvious testimony of this fact is the huge variety of drugs available in the commercial market today. These drugs that are developed to treat a disease, a chronic condition, or even something as mundane as the common cold would be available without the teams of medical researchers and other specialists who worked to make sure it received agency approval.
Regulatory affairs professionals are key players in drug development. They are the primary communications link between the company and agencies of various countries, and they are responsible for keeping up with the increasing scope and complexity of regulations both here and abroad.
In the pharmaceutical industry, Regulatory affairs professionals have expertise in the legal and regulatory environments, as well as in clinical research protocols. They are the primary interpreters of the laws and regulations for other members of the company's R&D, manufacturing, and compliance staff.