Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

• Pharmaceuticals
• Medical devices
• In vitro diagnostics
• Biologics and biotechnology
• Nutritional products
• Cosmetics
• Veterinary products

The regulatory professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labelling and advertising and post market surveillance.

Regulatory Affairs Job Profile:

• Drug Safety Associate
• Regulatory Affairs Executive
• Regulatory Affairs Officer
• QA