Two roles that overlap
Regulatory affairs usually manages the company's dealings with agencies: submissions, approvals, labeling, and correspondence with reviewers. Compliance usually asks whether the company's conduct after approval matches the rules, including how products are promoted and how the company deals with customers and health care providers. In smaller companies one person may hold both roles, which works until the two pull in different directions. Clear reporting lines matter, because a compliance officer who cannot reach senior leadership or the board has little practical authority. Regulators and prosecutors evaluating a company often look at how this function was resourced and whether anyone listened to it.
Documentation that stands up later
The documents this function produces are often the first ones regulators ask for. Keep submission histories, agency correspondence, and the reasoning behind decisions on labeling and promotional review. Complaint handling and adverse event records need to be complete and consistent with what was reported to the agency. Internal reviews of potential problems are not automatically privileged; when a review may lead to legal exposure, it is usually structured under the direction of counsel from the start. Teams also benefit from guidance on raising concerns in writing clearly and accurately, since casual emails about a regulatory issue can be read very differently in an investigation.
When outside counsel steps in
Companies typically bring in outside counsel for a new product pathway, an inspection with adverse findings, a warning letter, or a whistleblower complaint. We usually begin by learning the regulatory history of the product and the team's current processes. From there the work might be a response to an agency, an internal investigation, or a review of how promotional and reporting decisions are made. We also check whether an issue triggers a reporting duty to an agency on its own timetable. The aim is to support the internal team rather than replace it, since they know the product and the agency relationship far better than any outside adviser.
