What regulatory affairs is
Regulatory affairs (RA) is the function that gets healthcare products approved and keeps them compliant with the laws of every market where they are sold. It sits between a company and its regulators: FDA in the US, EMA and national authorities in Europe, and their counterparts elsewhere. RA professionals turn scientific and manufacturing data into the submissions regulators require, interpret what the rules mean for the business, and make sure the company keeps its commitments after approval.
The field is large and organized. The Regulatory Affairs Professionals Society (RAPS), founded in 1976, describes itself as “the largest global organization of professionals involved with regulatory and quality for healthcare products,” with more than 30,000 members in 114 countries. Its Regulatory Affairs Certification (RAC) is the best-known credential in the field.
Most people come to RA from somewhere else. A 2019 article in Frontiers in Pharmacology by William Bridges noted that few enter the field straight from undergraduate study, and only about one in seven has a degree related to the work.
For regulatory affairs in medical devices specifically, including strategy and the RA career path, see Medical Device Regulatory Affairs in 2026: Role, Responsibilities and Trends.
What regulatory affairs does across the product lifecycle
The same article described RA work as covering nearly every phase of a product’s life: strategy, cross-functional collaboration, manufacturing compliance, submissions, post-approval changes and safety reporting.
| Lifecycle stage | Typical RA work |
|---|---|
| Early development | Regulatory strategy; classification; pathway selection (for example NDA vs 505(b)(2), 510(k) vs De Novo); pre-submission meetings |
| Clinical | Clinical trial applications (IND, CTA, IDE); protocol amendments; regulator interactions |
| Submission | Compiling and publishing dossiers (eCTD for drugs, eSTAR for many devices); answering deficiency letters |
| Launch | Labeling and promotional review; registration in additional markets |
| Post-approval | Change assessments and supplements; annual reports; renewals; product information updates |
| Ongoing | Regulatory intelligence; inspection support; responses to Form 483 observations and warning letters |
In smaller companies one person may do all of this. In large companies the work splits into strategy, CMC regulatory, labeling, regulatory operations (publishing and submissions), and regulatory intelligence teams.
Regulatory affairs in pharma vs medical devices
The core skills are the same, but the frameworks differ.
| Area | Drugs and biologics | Medical devices |
|---|---|---|
| US pathway | IND, NDA, ANDA, BLA | 510(k), De Novo, PMA |
| US electronic format | eCTD | eSTAR for 510(k) and De Novo |
| EU framework | Directive 2001/83/EC and Regulation 726/2004 (being reformed) | MDR and IVDR |
| Post-approval changes | Supplements and annual reports under 21 CFR 314.70 | New 510(k) or documented assessment; PMA supplements |
| Quality system link | GMP (21 CFR 210/211) | QMSR (21 CFR 820, incorporating ISO 13485 since February 2, 2026) |
Five changes reshaping regulatory affairs in 2026
1. eCTD 4.0 is coming
RAPS reported in February 2026 that FDA has accepted eCTD v4.0 submissions since fall 2024 and plans to make v4.0 mandatory by 2029. ICH’s regional implementation table lists the other dates: Japan has required v4.0 for new applications since April 2026, the EU requires it for new centralized marketing authorization applications from Q1 2028 (strongly recommended from Q1 2027), and Health Canada plans voluntary use in 2028 and mandatory use in 2030. Regulatory operations teams need publishing tools and processes ready for both formats during the transition.
2. Structured device submissions
FDA has required eSTAR for 510(k) submissions since October 1, 2023, and for De Novo requests since October 1, 2025, according to Emergo by UL. Structured templates catch missing content before submission, but they also leave less room for inconsistency between sections.
3. Major EU reform
EU institutions reached a provisional agreement on the EU pharmaceutical legislation reform on December 11, 2025. According to Cooley, it cuts EMA’s standard review time from 210 to 180 days, changes regulatory data and market protection periods, and adds a six-month advance notice requirement for anticipated shortages. Formal adoption was expected in 2026, with transition periods likely between 18 and 36 months.
4. A tougher inspection climate
FDA announced on May 6, 2025 that it would expand unannounced inspections at foreign manufacturing facilities. Reed Smith reported that FDA issued 327 warning letters from July 1 to December 3, 2025, a 73% increase on the same period a year earlier. RA teams are increasingly involved in inspection readiness and responses, not just submissions.
5. AI on both sides of the table
On June 2, 2025, FDA launched Elsa, an internal generative AI tool used to summarize adverse events, compare labels and help prioritize inspections, as Morgan Lewis reported. FDA has said the models do not train on data submitted by industry. Morgan Lewis advised sponsors to expect AI-assisted review and to make sure submissions are well structured and internally consistent, because gaps and inconsistencies are more likely to be noticed. In January 2026, EMA and FDA jointly issued 10 guiding principles for good AI practice in drug development, including a risk-based approach and a defined context of use.
Where AI helps regulatory affairs, and where it does not
The use cases for AI in regulatory affairs are already clear.
Useful today, with human review
- Checking dossiers for internal consistency: the same dose, strength, specification or site name across modules
- Comparing labeling versions and highlighting differences
- Summarizing new guidances and flagging which products they affect
- Drafting responses to routine questions from structured data
- Checking submission content against a regulatory checklist before publishing
Still a human decision
- Regulatory strategy and pathway selection
- Deciding how to classify a change for reporting
- Commitments made to regulators
- Final sign-off on anything submitted
FDA’s April 2026 warning letter to Purolea Cosmetics Lab, in a GMP context, makes the general point: if AI is used to help create regulated documents, the company “must review the AI generated documents” for accuracy and compliance. The same logic applies to regulatory submissions.
Regulatory affairs readiness checklist
- Regulatory strategy documented for each product and market
- Submission tools and processes ready for eCTD 4.0 and eSTAR
- Regulatory intelligence process in place, with impact assessment
- Change control includes regulatory reporting assessment
- Labeling version control across markets
- Inspection readiness and 483 response process involves RA
- Policy on AI use in regulatory work, with human review defined
- Training plan for RA staff, including credentials where useful
Check regulatory documents with AskDona
The most common submission problems are not scientific. They are inconsistencies: a specification in Module 3 that does not match the one in the labeling, a site listed in one place and missing in another. AskDona reads dossiers, labels, SOPs and supporting records, checks them against FDA and EU requirements and your own standards, and shows each finding with the source page. Run a sample regulatory document assessment on a recent submission section. AskDona shows the evidence; your regulatory team decides.
FAQ
What is regulatory affairs? The function that obtains and maintains marketing approval for healthcare products by preparing submissions, interpreting regulations and managing compliance with regulators across the product lifecycle.
What is RAPS? The Regulatory Affairs Professionals Society, founded in 1976, a global professional organization for regulatory and quality professionals in healthcare products. It is linked to the RAC credential.
What does a regulatory affairs specialist do day to day? Prepares and reviews submissions, assesses changes for regulatory impact, reviews labeling, tracks new regulations and guidance, and supports interactions with regulators.
Will AI replace regulatory affairs professionals? Not the judgment parts. AI can speed up consistency checks, summaries and drafting, but strategy, classification decisions and sign-off remain human responsibilities.
When does eCTD 4.0 become mandatory in the US? FDA officials said in February 2026 that v4.0 would be mandatory by 2029. FDA already accepts v4.0 submissions.
References
All pages opened and checked by October 14, 2026.