Regulatory Affairs
Understand global drug regulatory frameworks, dossier compilation and submission processes.
Overview
This course covers regulatory requirements for drug approval across major markets including US FDA, EMA, CDSCO and ICH guidelines. Students learn dossier compilation (CTD/eCTD format), labeling requirements, regulatory strategy, post-approval changes and lifecycle management, preparing them for regulatory affairs roles in pharmaceutical and biotech companies.
Eligibility
- B.Pharm
- M.Pharm
- Pharm.D
- Life Sciences Graduates
- Freshers and working professionals
Course Duration
3 Months (Weekday & Weekend batches available)
Career Opportunities
- Regulatory Affairs Associate
- Regulatory Affairs Executive
- Dossier Compilation Specialist
- Regulatory Submissions Coordinator
- Drug Registration Associate
Training Features
- CTD/eCTD dossier compilation practice
- Case studies on FDA, EMA and CDSCO submissions
- Guidance from regulatory affairs professionals
- Certification recognized by industry partners
- Dedicated placement support
Enquire About Regulatory Affairs
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