Pharmaceutical Regulatory Affairs Diploma Program

Research and development in the pharmaceutical, biotechnological and medical device industries is incredibly stringent when it comes to regulations and quality. These are among the highest regulated industries in the world.

At AAPS, our Pharmaceutical Regulatory Affairs diploma program provides a deep and comprehensive background and training that will expertly prepare graduates to assume careers as regulatory professionals in order to address domestic and international laws and statutes.

Courses you’ll be taking in the diploma in Pharmaceutical Regulatory Affairs program include:

  • Introduction to Pharmaceutical, Biological/Biotechnology, Natural Health Products and Medicines
  • Introduction to International Food and Drug Laws, Regulations and Guidelines
  • New Drug Development
  • Introduction to Good Manufacturing Practices – Level I
  • Introduction to Pharmaceutical Manufacturing
  • Good Manufacturing Practices – Level II
  • Regulatory Submission
  • Preclinical –Drug
  • Intellectual Property
  • Clinical – Drug
  • Post Approval Activities and Compliance
  • Formularies and Reimbursement
  • Technical Writing and Scientific Communication
  • Chemistry Manufacturing and Control
  • Labeling and Product Summaries
  • Global Regulatory Strategies
  • Introduction to Clinical Studies
  • Good Manufacturing Practices – Level III
  • Generic Drugs
  • Natural Health Products
  • Biologics/Biotechnology Products
  • Medical Devices

Regulatory Affairs is a dynamic, constantly changing and very challenging profession that is absolutely essential in making sure safe and effective healthcare products are available worldwide. Regulatory Affairs covers a wide variety of disciplines and job responsibilities, many of which may begin during the product development and even continue on to when a product is widely available for use.

Regulatory Affairs professionals can become gainfully employed in the pharmaceutical industry, government and academia and are able to assume a variety of careers such as:

  • Document Control
  • Regulatory Affairs Associate
  • Regulatory Affairs Assistant
  • Project Coordinator
  • QA Associate
  • QA Assistant
  • Manufacturing Auditor
  • Quality Auditor