Regulatory Affairs Course for Pharmacy Graduates | RA Certification
Navigate the complex global regulatory landscape—submissions, dossiers, and compliance—to bring safe and effective pharma products to market.
What You'll Learn
- Global regulatory frameworks (FDA, EMA, CDSCO)
- CTD/M1–M5 dossier structure preparation
- Regulatory submission processes and strategies
- Post‑approval compliance and maintenance
- Regulatory intelligence gathering
- Electronic submission requirements
Career Opportunities
After completing this course, you'll be prepared for roles like:
- • Regulatory Affairs Specialist
- • Regulatory Submissions Coordinator
- • Regulatory Documentation Associate
- • Compliance Officer
- • Regulatory Affairs Manager
Salary Information
Entry-level RA professionals in India earn ₹4.5-7 LPA, with senior managers earning ₹15-25 LPA depending on experience
Comprehensive Course Syllabus
Module 1: Overview of Regulatory Bodies
- US FDA
- EMA
- CDSCO
- PMDA
- Global harmonization initiatives
Module 2: CTD Structure
- Quality
- Safety
- Efficacy
- Administrative info
- Module organization
Module 3: Submission Workflows
- eCTD publishing
- Rolling submissions
- Document management systems
Module 4: Post‑Marketing Commitments
- Label updates
- Renewals
- Pharmacovigilance link
- Compliance reporting
Module 5: Career Transition for Pharmacy Graduates
- Leveraging pharmacy education
- Industry networking
- Specialized RA roles
Prerequisites
- Understanding of drug development lifecycle
Frequently Asked Questions
What career opportunities are available after completing the Regulatory Affairs course?
After completing our Regulatory Affairs course, you can pursue roles such as Regulatory Affairs Specialist, Regulatory Submissions Coordinator, Regulatory Documentation Associate, Compliance Officer, Regulatory Affairs Manager.
Is this Regulatory Affairs course suitable for freshers?
Yes, our Regulatory Affairs course is specifically designed for freshers with no prior industry experience. We start with the fundamentals and gradually build to advanced concepts.
What is the typical salary for professionals in Regulatory Affairs?
Entry-level RA professionals in India earn ₹4.5-7 LPA, with senior managers earning ₹15-25 LPA depending on experience
Do I need prior pharma knowledge for the Regulatory Affairs course?
The prerequisites for this course are: Understanding of drug development lifecycle. We provide comprehensive learning materials to ensure your success.