M. Pharm (Regulatory affairs)

Regulatory affairs professional manages the process of working with project teams and interacting with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Council for Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.

In addition to regulatory affairs liaisons positions, there are vast arrays of other career opportunities either in health authority or pharmaceutical companies. Positions within regulatory affairs offer excellent job security. The reason is simply supply and demand: not enough people today have experience in regulatory affairs and at the same time, the FDA has increased its standards, requiring more supporting studies and paperwork before products can be approved for human use.

To be successful in this position, it helps to be very detail- and process-oriented, and to possess excellent writing, communication, and interpersonal skills.

Responsibilities of a Regulatory affairs Professional:

1. In Health Authorities:

a) Evaluation of Marketing Authorization Applications

b) Input for guidelines and guidance documents

c) Inspection of manufacturing premises

d) Support to Pharmaceutical Manufacturers

e) Monitoring of Drug Safety and Efficacy

2. In Pharma Industries:

a) Define Regulatory Strategy for drug development

b) Preparing Marketing Authorization Application or Dossier

c) To built amicable relationship with Health Authority

d) Establish proper Regulatory systems and processes

In Drug Regulatory Affair course students get to know the standard practices that need to be observed and followed to get quality pharmaceutical products developed by the formulation department. They are trained in making various regulatory documents which are expected by the various drug regulatory authorities all over the world for approving either drug for marketing or initiating clinical trials.

Intake of students: 12

Duration of course:­ 2 Years (04 Semester)

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