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Organisational Structure Regulatory Affairs Sector

The Regulatory function in a facility varies a lot dependent on the type of product being handled, and the size of the facility.

Smaller companies many only employ one Regulatory person, sometimes this is done on a part-time basis if the outfit is quite small.

In a pharma or biotech company, things are vastly different. Regulatory dossiers must be filed and maintained with the utmost of attention and accuracy. Large regulatory departments exist in MNCs with large presences here, and the staff in these areas must be well trained and educated. For smaller companies, their regulatory function is often outsourced to a consultancy company, although this can become a costly exercise when projects start becoming large and more complex.

Medical Devices operate under the ISO 13485 quality standard and different regulatory standards to pharma / biotech, and people working in this area must be familiar with these differences.

Many of the industries above require Regulatory Affairs function, which usually work closely with QA and people often move from QA into Regulatory and vice-versa roles, when the opportunity arises.