Expertise

Regulatory Affairs

Regulatory Affairs is a discipline and strategic function within the overall organisational structure of the life sciences companies that directly interacts with government regulatory agencies concerning regulatory approvals.

Roles

Regulatory Affairs is a broad function that is involved in all stages of product development, from chemistry, manufacturing and control submissions, clinical trial applications to submission and maintenance of marketing authorisation applications, labelling, etc. It is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical and medical device companies.