Pharmaceutical Management & Regulatory Affairs

Pharmaceutical Regulatory Affairs is a department in a pharmaceutical company that ensures that its organization complies with all of the regulations and laws pertaining to drug research. This department works with federal, state and local regulatory agencies on issues affecting drug research and development of the initial application phase for a new or generic drug, and licensing and marketing stages – making sure all operations and products meet required safety and efficacy standards.

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, such as the Food and Drugs Agency (FDA) and the European Union.

Regulatory affairs (RA), also called Government affairs, are a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries.

Regulatory affairs general areas:

• Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
• Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
• Advising their companies on the regulatory aspects and climate that would affect proposed activities. I.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.

Intake of students: 18
Duration of course:­ 2 Years (04 Semester)
Syllabus: Download