Regulatory Affairs Course in Dubai
The Regulatory Affairs course in Dubai explains how medicines and medical devices are registered and kept compliant with health authorities.
About the Regulatory Affairs course in Dubai
The Regulatory Affairs course in Dubai explains how medicines and medical devices are registered and kept compliant with health authorities. It helps pharmacists, quality staff and science graduates in the UAE who work for manufacturers, importers or distributors and deal with MOHAP, DHA or DOH.
Regulatory affairs manages the registration and compliance of medicines and medical devices with health authorities. Specialists prepare submissions, track approvals and make sure products stay within the rules after launch.
Our Regulatory Affairs training in Dubai is a 40 hours program available online, offline and hybrid, with batches on weekend and weekdays near Deira Clocktower. It suits life science graduates, pharmacists, nurses and healthcare staff moving into specialised roles. You practise each topic during the session and your trainer reviews what you produce, which is how the skill sticks. Learners often pair it with SAS Exams & Certification or CHFM. Classroom learners come to Mabrooka Building 04 on Al Muraqqabat Road, a short walk from Al Rigga Metro Exit 2, and online learners follow the same syllabus live. You can compare every option under Clinical & Healthcare courses. Send an enquiry to get the detailed outline, fee and upcoming batch schedule.
Watch: training at Solve Tech
Why Solve Tech
- Trainers from the fieldEngineers with design, contracting and facilities experience.
- Project-based learningYou complete the work yourself and your trainer reviews it.
- Flexible batchesWeekday, evening and weekend, in class or live online.
- KHDA-permitted instituteCourse completion certificate, with KHDA attestation for eligible courses.
- Central Deira locationNear Deira Clocktower and Al Rigga Metro Station, Exit 2.
- Honest course adviceAn advisor matches the course to your background.
What You Learn in the Regulatory Affairs Course in Dubai
- Explain the product registration pathway
- Compile dossiers in Common Technical Document format
- Understand UAE and GCC registration requirements
- Manage variations and renewals
- Read labelling and artwork requirements
- Work with GMP and quality documents
- Understand basic medical device classification
- Communicate with authorities and internal teams
Who Should Take the Regulatory Affairs Course
- Pharmacists working for importers and distributors
- Quality assurance staff widening their scope
- Science graduates seeking industry roles
- Medical device and cosmetics company employees
Tools Covered in the Regulatory Affairs Course
- ICH CTD (M4)
- eCTD (overview)
- GCC Guidelines for Drug Registration
- ICH Q-series guidelines
- GMP (WHO and PIC/S)
- ISO 13485 (overview)
- MDR classification concepts
Benefits of the Regulatory Affairs Training Course
- Gives a clear view of how products reach the UAE market
- Helps local agents and distributors prepare cleaner submissions
- Builds familiarity with dossier structure used across the Gulf
- Supports movement into regulatory roles in pharma and device companies
Regulatory Affairs Course Outline
Module 1: Regulatory Environment
- Role of regulatory affairs
- UAE health authorities
- International regulators overview
- Product life cycle
Module 2: Drug Development Basics
- Preclinical and clinical phases
- Generic and innovator products
- Bioequivalence overview
- Quality, safety and efficacy
Module 3: Registration in the GCC
- GCC central registration concept
- UAE submission steps
- Documents from the manufacturer
- Timelines and fees awareness
Module 4: Dossier Preparation
- CTD modules 1 to 5
- eCTD structure overview
- Quality documents
- Labelling and package inserts
Module 5: Post-Approval Activities
- Variations and changes
- Renewals
- Pharmacovigilance links
- Recalls and field actions
Module 6: Medical Devices and Other Products
- Device classification
- Technical file contents
- Cosmetics and supplements overview
- Import and clearance basics
Module 7: Practical Exercise
- Review a sample dossier index
- Check labelling against a checklist
- Plan a variation submission
- Present a regulatory strategy
Guides to read before you enrol
Certificate
You receive a Solve Tech course completion certificate after the course and its assessment. KHDA-attested certificates are available for eligible courses. How our certificates work
Related Clinical & Healthcare courses
View allFAQ About Regulatory Affairs Courses
How long is the Regulatory Affairs course?
The Regulatory Affairs course is 40 Hours.
Who should take the Regulatory Affairs course?
Pharmacists working for importers and distributors; Quality assurance staff widening their scope; Science graduates seeking industry roles; Medical device and cosmetics company employees.
Which tools are covered in the Regulatory Affairs course?
ICH CTD (M4), eCTD (overview), GCC Guidelines for Drug Registration, ICH Q-series guidelines, GMP (WHO and PIC/S), ISO 13485 (overview), MDR classification concepts.
Does this course give me a licence to work as a regulatory officer?
No. It builds knowledge and skills. Any approvals needed to act for a company are set by the relevant UAE authority and the employer.
Is the course focused only on medicines?
Medicines are the main focus. Medical devices and other health products are introduced so you see how the rules differ.
Is the Regulatory Affairs course available online?
Delivery modes for this course: Online, Offline, Hybrid. Ask an advisor for the next batch in the mode you prefer.
Can I attend on weekends?
This course runs on: Weekend & Weekdays.
Where is the Regulatory Affairs course held in Dubai?
At Solve Tech Training Institute, Office M09, Mabrooka Building 04, Al Muraqqabat Road, near Deira Clocktower. The nearest metro is Al Rigga Station, Exit 2.
What is the fee?
Fees depend on the format and batch. Send an enquiry to receive the current fee.
About Solve Tech Training Institute
Solve Tech Training Institute is a KHDA-permitted technical and occupational skills training centre in Deira, Dubai. We teach engineering, technical and professional courses in the classroom, live online and on site for companies, with trainers who work in the fields they teach. This page is published by the Solve Tech training team and was last updated in October 2026.
About usAccreditation and certificatesPhotos of our labsContact and map
Al Muraqqabat Road, near Deira Clocktower
Dubai, UAE
+971 50 691 4688