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Regulatory affairs certification: RAC, courses and what employers check
Regulatory affairs certification usually means the RAC, the Regulatory Affairs Certification awarded by RAPS, the Regulatory Affairs Professionals Society. It is a professional credential earned by passing an exam, and it is renewed through continuing education. It is not a licence: no regulator requires it, and many regulatory professionals in Europe work without it. What an employer checks first is whether you can do the job, which means knowing the dossier, the procedures and the authorities you will deal with.
- 5 related courses
- 44 hours of audio across them
- certificate and training record
- delivered in 72 hours
What is RAC certification?
RAPS runs the RAC exams. There are two: RAC-Drugs for medicines and RAC-Devices for medical devices. The exams test regulatory knowledge across the product lifecycle, from development and submission to post-approval changes. The credential is well known in the United States and Canada and is recognised by many international companies. In Europe it is respected but less common, and job adverts rarely make it a condition.
Does a regulatory affairs certification help in Europe?
It can help a CV, but European employers mostly hire for knowledge of the EU system. That means Directive 2001/83/EC and the regulation behind the centralised procedure, the four routes to a marketing authorisation, the role of the EMA and the national authorities, variations and renewals, and the CTD dossier submitted as eCTD. A candidate who can explain why a submission failed validation is worth more to a regulatory manager than a candidate with a credential and no submissions.
Which regulatory affairs course should a beginner take?
Start with the system before the detail. A beginner needs to know who decides what, which procedure fits which product, what the dossier looks like and which systems the team uses every day. After that, learn the parts your company relies on most: variations for a generic company, scientific advice for an innovator, the eCTD for anyone who builds or publishes dossiers.
What a regulatory team actually needs
New starters need the European essentials and a clear picture of their first month. Experienced staff moving from another region need the EU differences and the people they will deal with across Europe. Everyone who touches a dossier needs the CTD and eCTD rules. The courses below cover those layers by role, with a recorded questionnaire at the end of each module. If you want the RAC as well, these courses are useful background for the medicines exam, but you register and sit the exam with RAPS.
This guide belongs to Training for Regulatory affairs in pharma: 227 audio courses, 227 courses.
Courses that teach this, priced per learner per year
Each course is audio modules in three lengths, with workbook, transcript, a recorded questionnaire per module, a certificate and the training record. Prices are the list price per learner for a year; the price falls with more learners.
- Regulatory affairs: everything Europe expects of you, in one course10 modules · 10 hours of audio · Regulatory affairs · 90 EUR per learner per year
- Regulatory affairs: your first month in pharma, starting from zero8 modules · 8 hours of audio · Regulatory affairs · 72 EUR per learner per year
- Regulatory affairs: the ten documents and systems you will live in5 modules · 5 hours of audio · Regulatory affairs · 45 EUR per learner per year
- Regulatory affairs: working with European counterparts, minus the friction6 modules · 6 hours of audio · Regulatory affairs · 54 EUR per learner per year
- European Union: eCTD that passes validation first time, module by module15 modules · 15 hours of audio · RA, QA, BD · 135 EUR per learner per year
Questions about regulatory affairs certification
What is RAC certification?
RAC stands for Regulatory Affairs Certification. RAPS awards it after an exam, in separate versions for medicines and for medical devices. Holders keep it by earning continuing education credits and recertifying every three years. It is a recognised credential, especially in North America.
Is regulatory affairs certification required to work in regulatory affairs?
No. No regulator in the EU or elsewhere requires a personal certification to prepare or submit a dossier. Employers look at your degree, your experience with real submissions and your knowledge of the procedures. A credential can help a CV, but it does not replace that experience.
What is the difference between a regulatory affairs course and a certification?
A course teaches the content and gives you a record of completion. A certification such as the RAC is awarded by an independent body after an exam and has to be maintained. Many people take courses first and decide on a certification later, once they know which market they work in.
Is there a European regulatory affairs course?
Yes. Several universities run master's programmes in regulatory affairs, and short courses cover the EU procedures, the CTD and eCTD, and working with the EMA and national authorities. Pick one that teaches the current EU legislation and the procedures your company actually uses.
Can I study regulatory affairs online?
Yes. Most of the knowledge a new regulatory professional needs, such as the dossier structure, the procedures and the lifecycle of a licence, can be learned online. The hands-on part comes from working on real submissions with a more experienced colleague checking your work.
Is the course certificate a regulatory affairs certification?
No. The courses below do not award the RAC and are not linked to RAPS. The certificate records that a named person completed the course and its questionnaires, with hours, guideline version and date. It is evidence of training, not a professional qualification or an accreditation.
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