What is regulatory affairs?

Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.

TOPRA was established in 1978 as a professional membership organisation to represent and support these professionals.

The role of the regulatory professional

Regulatory professionals are responsible for:

1. Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products
2. Advising on legal and scientific restraints and requirements
3. Collecting, collating and evaluating scientific data
4. Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned
5. Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole
6. Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

Additionally, the regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially.

“How I started out...”

Four regulatory affairs professionals share the story of their careers so far, and how they got to where they are now. Read more