Regulatory Affairs Training Program
Pharma • Biologics • Medical Devices • Quality & Compliance
Advance your career in Regulatory Affairs with practical, global training
Gain industry-ready knowledge in regulatory documentation, global submissions, compliance, clinical trials, and post-marketing activities. Learn to navigate FDA, EMA, CDSCO, and WHO regulatory landscapes through hands-on projects and dossier preparation practice.
Program Curriculum
Foundations
- Introduction to Regulatory Affairs & Industry Overview
- Global Regulatory Frameworks and Agencies
- Drug Development Process & Clinical Research Basics
- Regulatory Documentation Lifecycle
Regulatory Submissions
- Common Technical Document (CTD & eCTD) Formats
- IND, NDA, ANDA, MAA Preparation
- Dossier Compilation for US, EU, and India
- Electronic Submission Systems & Standards
International Guidelines
- ICH, WHO, and PIC/S Guidelines
- FDA 21 CFR Regulations
- EMA & CDSCO Requirements
- Regulatory Harmonization Practices
Compliance & Quality Systems
- Good Manufacturing Practice (GMP)
- Good Clinical & Laboratory Practices (GCP & GLP)
- Pharmacovigilance and Safety Reporting
- Audit Management & CAPA
Medical Devices & Biologics
- Medical Device Regulation (MDR 2017/745)
- FDA 510(k) & PMA Process
- IVD and Biologics Registration
- Post-Market Surveillance
Labeling, Packaging & Advertising
- Labeling Standards & Requirements
- Patient Information Leaflets
- Promotional Material Compliance
- Serialization & Packaging Controls
Capstone & Practice
Work on mock dossier preparation, submission simulation, and variation management exercises. Includes live projects for practical exposure.
Assessments
Module tests, case studies, and final submission evaluation.
Capstone Project
Hands-on CTD dossier preparation with simulated submission to regulatory authorities.
Certification Support
Guidance for RAC, RAPS, and national-level regulatory certification exams.
Program Benefits
Global Curriculum
Covers regulatory frameworks across major markets — US, EU, India, and WHO standards.
Practical Industry Focus
Hands-on learning with real-world case studies, dossier samples, and compliance exercises.
Career Support
Resume assistance, interview prep, and placement opportunities in pharma, biotech, and CROs.
Career Roles & Pathways
Graduates of this program can pursue roles in regulatory operations, quality assurance, and compliance within healthcare industries.
- Regulatory Affairs Associate / Specialist
- Regulatory Submissions Coordinator
- Quality Assurance Executive
- Pharmacovigilance Associate
- Clinical Research Associate
- Documentation & Compliance Officer
- Medical Device Regulatory Specialist
- Regulatory Consultant
Industry Sectors
Pharmaceutical, Biotechnology, Medical Device, CROs, and Regulatory Consultancies.
Career Growth
Associate → Specialist → Manager → Global Regulatory Head roles.
Certifications
RAC (US/EU), RAPS Membership, and country-specific certifications enhance opportunities.
What You Will Learn
- Understand the global regulatory environment and its key agencies.
- Prepare CTD/eCTD dossiers for pharmaceuticals and devices.
- Interpret and apply ICH, FDA, EMA, and CDSCO guidelines.
- Manage clinical trial documentation and submissions.
- Ensure compliance with GMP, GCP, and pharmacovigilance standards.
- Perform regulatory audits and manage CAPA reports.
- Oversee post-approval product lifecycle activities.
- Handle labeling, packaging, and promotional compliance.
- Develop strategic regulatory intelligence for global submissions.
Ready to start your Regulatory Affairs career?
Join the next cohort — limited seats available. Get real-world regulatory experience, certification guidance, and placement support.
Frequently Asked Questions
Do I need a science background?
A life science or pharmacy background is preferred but not mandatory. Fundamentals are covered in the initial modules.
Will I get placement support?
Yes — resume writing, interview guidance, and placement assistance with partner companies are included.
Which certifications can I pursue after this?
You can prepare for global certifications like RAC (US/EU), RAPS, or regional regulatory certifications with our guidance.