Regulatory Affairs

Pharmaceutical Regulatory Affairs is relatively a new profession that deals with the registration of medicinal and other health care products with various regulatory agencies to seek the marketing authorization for the designated market or country. Every nation has established or authorized a body to regulate the Quality, Safety and Efficacy (QSE) of the medicinal products to be sold in their territory. Hence, the pharmaceutical, research and clinical industries are obligated to register their medicinal product by submitting appropriate applications and supporting data to prove the QSE of the drug products before they are commercialized.

A Regulatory Affairs (RA) professional will serve as a scientific bridge between the govt. regulatory authorities such as US FDA, EMA, CDSCO etc., and the pharmaceutical industries and plays a key role in the development, approval and surveillance of safe and effective healthcare products worldwide. They ensure compliance with applicable laws and regulations in the development and commercialization of medicinal products.

RA professional is responsible to prepare Marketing Authorization Application (Dossier) in the required format as per the stipulated country specific regulations and guidelines and presentation of documents to the Regulatory Agencies or Authorities. RA professionals should read, understand and interpret the country specific regulations and guidelines and provide scientific guidance to the pharmaceutical & research industries to generate the necessary firsttime-right scientific data to justify the Quality, Safety and Efficacy of a medicinal product thereby accelerating the registration and approval of the health products.

RA professionals are in great demand across the globe with lucrative job opportunities. It is among one of the highly paid professions in the pharmaceutical and life sciences industry. Potential employers for RA professionals also include the govt. agencies such as CDSCO, US FDA, Health Canada, UK MHRA, TGA Australia etc. RA is a challenging subject and always evolving with new technology in medicine and its corresponding regulations. An RA professional will enjoy the freedom of working remotely and also to work as consultant to multiple organizations. Regulatory Affairs covers a wide variety of disciplines and job responsibilities such as Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs, Clinical Regulatory Affairs, Medical Device Regulatory Affairs, Biologics Regulatory Affairs, Natural Health Products Regulatory Affairs, Cosmetics Regulatory Affairs etc.

An ideal RA professional should have a strong business acumen, curiosity of new learning, an eye for details, strong scientific knowledge, communication skills and should continue to update their knowledge to adjust in the rapidly shifting biopharmaceutical industry. RA professionals plays key role in the industry in bringing the products into commercialization and making sure safe and effective healthcare products are available worldwide.

This course is personalized to meet professional and developmental needs and enables students to acquire strong fundamental knowledge in the field of global regulatory affairs. Having a certification in this course will help students to stand out of the crowd and gives confidence to the employer to hire you as their candidate of choice.

For detailed information related to the course please download the brochure.