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What is Regulatory Affairs?

In its simplest sense, just what is a Regulatory Department of a Pharmaceutical Company. The truth is that many people outside of Regulatory are not really sure what the role of the Department actually is.

Some think all Regulatory does is advise a company on what the various global regulations are and how they apply, and while that is a vital role of RegAffairs, it is not the sole mission behind the department. Others think Regulatory is there to ensure the company gains advantages over its competitors, and again while this is a role RegAffairs plays, it is also not their primary function.

The Regulatory Department is your companies conduit to Health Authorities. It is your direct line of communication to those regulators who will be making decision regarding your products and their development. However, this works both ways. The Regulatory Department is also the Health Authorities conduit to the company. It is this Department which will receive the communications from agencies such as the FDA, EMA, Health Canada, or the TGA.

Realizing that the primary role of Regulatory is to act as that conduit will open up new avenues of understanding for a company. It is the role of Regulatory to help create the dialogue which shapes drug development while at the same time help to ensure that the company understands the will of the Health Authorities. A good Regulatory Head can and will ease the impact of negative communications by ensuring a good working relationship with the Agencies.

This is why it is critical when looking at Regulatory consultants to look closely at their interactions with Health Authorities in general, and not necessarily their interactions with specific divisions. A good reputation crosses divisional boundaries regardless of the specific familiarity with that particular group. Additionally, you want someone who has experience across both large and small companies with the experience to provide those extensive solutions your company may be facing. The goal of a Regulatory consultant is to help you navigate the waters of the Health Authorities streams and rivers, but your internal team must still steer the boat.

Trust your internal team to know the immediate players at the agency, and trust your consultant to pull you through the overall process. Together that gives you a recipe for success!

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