What steps should I take to enter the field of Regulatory Affairs?

by Dr. Yashashwini Reddy | Apr 10, 2025

To embark on a career in Regulatory Affairs, it is essential to obtain a bachelor’s degree in a life sciences discipline, acquire relevant experience through internships or entry-level positions, and contemplate pursuing advanced degrees or certifications to...

How can someone grow professionally in the field of regulatory affairs?

by Dr. Yashashwini Reddy | Apr 10, 2025

A typical career trajectory in Regulatory Affairs may include the following positions: – Regulatory Officer/Executive/Associate – Senior Associate – Manager – Senior Manager – Director – Senior Director – Head of Department...

Which core skills are valued in regulatory affairs professionals?

by Dr. Yashashwini Reddy | Apr 10, 2025

The need for regulatory affairs (RA) professionals is prominently recognized within the pharmaceutical sector, consulting firms, clinical research organizations, and regulatory bodies. As I contemplated my career shift from laboratory science to regulatory affairs, I...

What is the difference between regulatory affairs and quality assurance?What is the role of Regulatory Affairs in drug development?

by Dr. Yashashwini Reddy | Apr 8, 2025

Feature Regulatory Affairs Quality Assurance Focus Legal compliance and market access Product quality and consistency Scope Entire product lifecycle, with an emphasis on regulatory requirements Entire product lifecycle, with an emphasis on quality standards Primary...

What are the different types of regulatory submissions (e.g., INDs, NDAs, BLAs, PMAs)? What is the difference between NDA and ANDA?

by Dr. Yashashwini Reddy | Apr 8, 2025

Various types of regulatory submissions are essential in the pharmaceutical and medical device industries. These include Investigational New Drug (IND) applications for clinical trials, New Drug Applications (NDAs) for new pharmaceuticals, Biologics License...