Regulatory Affairs

Inside a research institution, regulatory affairs is the function responsible for determining which government regulatory frameworks apply to a given study and for preparing, submitting, and maintaining the filings those frameworks require. It typically sits alongside — but is organizationally and functionally distinct from — the Institutional Review Board (IRB), the sponsored-programs or grants office, and research integrity/compliance offices. At many universities and academic medical centers it is a named unit (an “Office of Regulatory Affairs,” “Regulatory Support,” or similar), often housed within the clinical research or research-compliance infrastructure.

What the function actually does

For research conducted or sponsored by an institution rather than a pharmaceutical or device company, regulatory affairs work centers on a recurring set of tasks:

• Determining applicability — deciding whether a proposed study involves an investigational drug, biologic, or device under FDA jurisdiction, or triggers biosafety, controlled-substance, radiation-safety, or export-control review, before the study can proceed.
• Preparing and filing submissions — most notably an Investigational New Drug (IND) application under 21 CFR Part 312 for a drug or biological product used in a clinical investigation, or an Investigational Device Exemption (IDE) under 21 CFR Part 812 for a device study. 21 CFR 312.3 defines an “investigational new drug” simply as a new drug or biological drug used in a clinical investigation; under Part 812, a device study is classified as significant risk (SR) or nonsignificant risk (NSR), which determines whether a full IDE application and FDA approval are required or whether abbreviated requirements (IRB approval, labeling, informed consent) apply instead.
• Supporting investigator-held applications — much institutional FDA-regulated research is not sponsored by a company but by the investigator personally, filed as an Investigator IND or Investigator IDE. The regulatory affairs office typically does not become the legal sponsor, but assembles the submission, tracks correspondence with FDA, and helps the investigator meet the ongoing sponsor obligations that come with holding an IND/IDE — safety reporting, annual reports, and recordkeeping.
• Maintaining the regulatory record — protocol amendments, safety reports, correspondence with the FDA or other regulator, and documentation of continued applicability determinations, for as long as the study or the resulting product development continues.
• Advising on non-FDA regulatory frameworks — biosafety and recombinant/synthetic nucleic acid oversight (often via an Institutional Biosafety Committee), controlled-substance registration for research involving scheduled drugs, and, for international collaborations, export-control screening.

How it relates to IRB review, GCP, and Good Laboratory/Manufacturing Practice

Regulatory affairs and IRB review answer different questions about the same study. IRB review asks whether the study is ethically sound and adequately protects participants; regulatory affairs asks which government filings and product-specific rules apply and ensures they are made and kept current. A study can need both, one, or neither depending on what is being tested. IRB/REC approval, and what does and doesn’t need it, is covered separately.

Good Clinical Practice (GCP) is the international ethical and scientific quality standard for how a clinical trial is designed, conducted, recorded, and reported — it governs day-to-day trial conduct once a study is underway. Regulatory affairs work happens earlier and in parallel: determining that a study needs an IND/IDE in the first place, and filing it, is a precondition for the study existing at all; GCP then governs how it is run. Similarly, Good Laboratory Practice (GLP) governs the nonclinical safety studies that typically support an IND submission, and Good Manufacturing Practice (GMP) governs how the investigational product itself is manufactured — both are inputs the regulatory affairs function has to document as part of assembling an IND or IDE package, rather than separate offices’ concerns.

How this differs from “regulatory affairs” as an industry career field

Searches for “regulatory affairs” most often surface the broader professional field associated with pharmaceutical, biotechnology, and medical-device companies — the discipline the Regulatory Affairs Professionals Society (RAPS) represents, whose Regulatory Affairs Certification (RAC) is a recognized industry credential. Industry regulatory affairs professionals typically manage a product’s full regulatory lifecycle: nonclinical development, IND/marketing-application strategy, labeling and advertising review, and post-market surveillance, often across multiple products and jurisdictions, for a company that is itself the sponsor.

The research-institution version of the function, described above, is narrower and study-specific: supporting individual investigator-initiated studies through the applicable regulatory pathway, most often within a university, academic medical center, or research institute rather than a company. The two fields share regulatory vocabulary and reference the same underlying FDA (and, outside the US, equivalent national or regional) frameworks, and career movement between them is common, but they are organizationally distinct: one serves a company’s product portfolio, the other serves an institution’s research portfolio.

References

• FDA, Investigational New Drug (IND) Application — fda.gov/drugs/types-applications/investigational-new-drug-ind-application
• 21 CFR Part 312 (Investigational New Drug Application) — ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312
• 21 CFR Part 812 (Investigational Device Exemptions) — ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812
• RAPS, About the Regulatory Profession — raps.org/Who-We-Are/About-the-Regulatory-Profession