Pharma Regulatory Affairs

Pharma Regulatory Affairs (12 Months Program)

The industry program aims to prepare aspirants for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. to equip them with the educational foundation that will help them advance in the regulatory affairs profession. The course will provide the student with the fundamentals required in both regulatory affairs and quality operations. This course is designed to give industry level education in field of legal and regulatory issues. These issues are very critical to Pharma companies, Clinical Research Organization, Bio Tech companies. The course focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

The course has been framed with the following objectives

• To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
• To create experts in the field of RA documentation and research
• To help students build their career in RA and become RA professionals.
• To provide students with a global knowledge of Regulatory Affairs.

Career Opportunities

As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in regulatory affairs. The students of the program will have an understanding of the regulatory processes involved in biotechnology, medical device, pharmaceutical and food products. Students will become eligible for occupations involving drug or medical device submissions and quality assurance functions and roles. The individuals who are interested in pursuing a career in regulatory affairs would get a thorough understanding of current regulations and their application to the development and commercialization of drug, biologic and biodevice products. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes. The course would facilitate the participants with the understanding of th e areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.

• Pharma Regulatory Affairs Consultant
• Regulatory Officer

For further details and enquiries
Call:0120-4320801/02
Mob:09810535368,9818473366
E-mail : info@bii.in,