Intake:15

Regulatory affairs is an industry that oversees how drugs, foods and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use. Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. This course is designed to impart fundamental knowledge on various Good Regulatory Practices viz., cGMP, GLP, GALP and GDP for Pharmaceuticals, Cosmetics, Food & Nutraceuticals, Medical devices, In-vitro Diagnostic Medical Devices (IVDs) and biological products and understand the rationale behind these requirements and will propose ways and means of complying with them. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products and cosmetics in regulated and semi-regulated countries. The various job opportunities are as Regulatory Compliance & Regulatory affair assistant, Regulatory affair associates, Preparation of Registration Dossier, Documentation, Administrator and Medical Information Associates, Regulatory Affair Consultants, Regulatory Food Safety Scientist etc.