Regulatory Affairs

What is Regulatory Affairs?

The Regulatory Affairs group is tasked with ensuring compliance to regulatory body requirements and setting the strategy around communications with the agency. There are several distinct functions which fall under the Regulatory umbrella within a pharmaceutical company including Regulatory Strategy, Regulatory Ad/Promo, and Regulatory Labeling.

What is Regulatory Strategy?

Regulatory Strategy team members often sit on cross-function development teams and help ensure appropriate development of clinical trials from the perspective of the local regulatory requirements and what would be needed in order to achieve the aspired labeling. There may be several things the regulatory representative would be looking for in the development of a clinical trial including choice of the right endpoints, powering for a minimally acceptable result, and having a general study design that is in line with local regulatory guidance. Regulatory Strategy also deals with communications with the regulatory body around the time of label-expansion and these team members will often travel to the agency to have discussions around development details and submission of applications for new drugs or updated labels.

What is Regulatory Advertising and Promotion (Ad/Promo)?

An important function of the Regulatory Affairs group is in reviewing materials for external communications in order to ensure compliance with regulatory guidance and to minimize the regulatory risk that the company is taking. Member of the ad/promo team are involved in various review committees (often shortened to RC) for the company and may review things including marketing materials for publication or media, deliverables for use by field teams such as sales reps, and so on.