Regulatory affairs (RA) professionals play critical roles in a pharmaceutical industry because it is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. The role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by global regulators and ensure that those are conducted in accordance with the regulations & guidelines established by regulatory authorities.
Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries and an art of collecting, analyzing and communicating the risks and benefits of health care products to regulatory agencies and public all over the world. It is also a science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products. All medicines must meet three criteria: be of good quality, safe and effective. The judgments about medicines quality, safety and efficacy should be based on solid science. Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. Professionals must combine knowledge of the business, legal and pharmaceutical industries to determine if regulations are being followed and in many cases form the link between pharma companies and regulatory authorities.
