In a regulatory context, what is the role of a subject-matter expert (SME)?

• A. To replace the project manager.
• B. To provide generic opinions without checking specifics.
• C. To identify applicable requirements and help close gaps through expert guidance.
• D. To approve all changes without review.

Answer: (C)

Key idea: in a regulatory context, the role of the subject-matter expert is to identify which requirements apply to the project and help close gaps through expert guidance. The SME uses deep knowledge of the rules to interpret what regulations require for the specific situation, translate those rules into concrete project requirements, and spot where current practices fall short. They then provide targeted recommendations to address those gaps and support the implementation of compliant controls, documentation, and processes, verifying that the project meets the regulatory standards. This isn’t about managing the project or giving generic opinions—it's about applying the actual regulatory requirements to the work and guiding proper changes. It also isn’t about approving every change on their own; change approvals follow formal governance and review procedures.