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“With the most up-to-date regulatory affairs Guidelines and innovative approaches to learning, we prepare our students for a successful career in regulatory affairs.”
In the Certification in Advanced Regulatory Affairs course, the candidate will comprehensively understand legal, scientific, and business concerns to perform their work effectively. You will know that products are developed and marketed within the legal framework and as per recommended guidelines.
Join BCRI’s Certification in Advanced Regulatory Affairs — a job-oriented online course designed for students and professionals aiming to work in regulatory roles within pharmaceutical companies and CROs.
This course provides an understanding of legal, scientific, and business concerns that are essential for the successful practice of regulatory affairs.
It also covers the legal framework and recommended guidelines. Advanced Regulatory Course will help you prepare product labels and arguments for new drugs/medical device licenses, submit product information to agencies, retrieve regulatory cases, and screen regulatory sites.
The regulatory Affair course will give you a good understanding of regulatory guidelines various regulatory authorities provide.
Understand key terms and concepts used in regulatory documentation, submissions, and compliance reporting.
Get trained on major international guidelines including ICH, US FDA, EMA (Europe), Health Canada, and CDSCO (India) — essential for working in multinational regulatory roles.
Learn how to prepare and submit regulatory dossiers in CTD/eCTD format, including module-wise breakdowns and document requirements.
Gain insights into variations, renewals, labeling changes, and pharmacovigilance coordination post product approval.
Strengthen your skills with hands-on case studies and real-world examples of regulatory submissions and communications.
Regulatory Affairs is a critical function in the pharmaceutical industry, ensuring that drugs are developed, approved, and marketed in compliance with health authority regulations. With the growing complexity of global regulatory environments, there is a rising demand for professionals trained in drug regulatory processes.
BCRI’s Certification in Advanced Regulatory Affairs is designed to help you build practical skills and domain expertise to succeed in this high-impact field.
Learn submission and compliance processes for major markets — including US FDA, EMA (EU), Health Canada, and CDSCO (India).
Gain hands-on understanding of preparing drug submissions in Common Technical Document formats — essential for global approvals.
Unlike generic courses, this program focuses exclusively on drug regulatory affairs, not devices — ensuring deep and relevant domain training.
From IND/NDA filings to post-marketing variations and communication with health authorities, you'll learn exactly what employers are looking for.
By completing this course, you’ll build a solid foundation in regulatory science and develop skills that are directly applicable to global regulatory roles.
✅ Key Skills You’ll Develop:
Engage with industry experts through real-time discussions and Q&A.
Revisit lectures anytime with 3-month access to recorded sessions on the BCRI Class app.
Learn from experienced professionals working in clinical research.
Work on real-world scenarios to develop job-ready skills.
Get help with resume building, mock interviews, and job referrals.
Hands-on training with real-time tools
The Certification in Advanced Regulatory Affairs program at BCRI covers the core regulatory domains essential for careers in drug approval, compliance, and submissions across global markets. The curriculum is structured to blend theoretical knowledge with real-world regulatory applications.
Understand the roles and responsibilities of major health authorities like US FDA, EMA (Europe), CDSCO (India), MHRA (UK), and Health Canada.
Learn how regulatory processes integrate with clinical trials — including regulatory planning, approvals, and ethics committee coordination.
Explore the principles of ICH-GCP and how they impact clinical development and trial documentation.
Get introduced to GMP compliance and how regulatory bodies assess manufacturing standards during inspections and submissions.
Master the preparation of regulatory dossiers including CTD and eCTD formats for IND, NDA, ANDA, and global submissions.
Learn the basics of IPR, patents, data exclusivity, and their impact on drug development and registration.
Understand the regulatory considerations involved in marketing authorization, drug labeling, and international trade of pharmaceuticals.
Gain knowledge of post-marketing surveillance, inspections, regulatory audits, and how to maintain ongoing compliance
Flexible Learning, Career-Focused Training
| Feature | Details |
|---|---|
| Course Name | Certification in Advanced Regulatory Affairs |
| Duration | 2 Months (Live Online Classes) |
| Mode of Delivery | Live Instructor-Led Online Sessions (with access to recordings & notes) |
| Focus Area | Drug Regulatory Affairs (Not medical devices) |
| Key Topics Covered | CTD/eCTD, IND, NDA, ANDA, ICH, US FDA, EMA, CDSCO guidelines |
| Tools/Formats Used | CTD Module Structures, Dossier Preparation Templates |
| Eligibility | B.Pharm, M.Pharm, B.Sc, M.Sc, MBBS, BDS, BHMS, BAMS, or professionals |
| Assessment | Assignment-based evaluation + Certification on successful completion |
| Certificate | BCRI Digital Course Completion Certificate |
| Placement Support | Resume prep, mock interviews, and job referrals |
Completing BCRI’s Certification in Advanced Regulatory Affairs prepares you for specialized roles in the regulatory domain of the pharmaceutical and biotechnology industry. As global regulations continue to evolve, the demand for qualified regulatory professionals is rising across India, the United States, Canada, Europe, and beyond.
Whether you’re a fresh graduate or a working professional, this course gives you the skills and confidence to step into high-demand regulatory positions.
Graduates of this program benefit from interview preparation, resume building, and career guidance designed specifically for global job markets. While BCRI does not guarantee placement abroad, our training helps candidates meet international employer expectations with confidence and clarity.
📢 BCRI offers complete placement support within India and guidance for international job applications — helping students build strong professional profiles for global clinical research roles.
Take the next step in your career with our industry-recognized Online Regulatory Affairs Course. Secure your spot today!
The course spans 1.5 months and is delivered through live online sessions. Participants also receive access to class recordings and comprehensive study materials for flexible learning.
This program is specifically tailored to drug regulatory affairs. It does not cover medical device regulations, ensuring a concentrated and in-depth understanding of pharmaceutical regulatory processes.
The course requires candidates to be familiar with clinical trial fundamentals. There will be a brief discussion in class about Pharmacovigilance.
Recommend Course: Certification in Pharmacovigilance & Basics of Regulatory Affairs.
The course encompasses:
Graduates and postgraduates in Life Sciences, Pharmacy, Medicine (including BAMS, BHMS, BDS), Nursing, Biotechnology, or related fields are eligible. Working professionals aiming to transition into regulatory roles are also encouraged to apply.
Yes. The course content follows CTD/eCTD, IND, NDA, ANDA, ICH, US FDA, EMA, CDSCO guidelines — making it suitable for international roles in CROs, pharmaceutical companies, and research hospitals.
Yes! Our Online REgulatory Affairs Course is fully accessible to students across the United States, including major cities like New York, Los Angeles, Chicago, Houston, Boston, and San Francisco. Live sessions are scheduled to suit multiple time zones.
Absolutely. Students from Toronto, Vancouver, Montreal, Calgary, Ottawa, and other Canadian cities have successfully enrolled in our online program. We follow Health Canada and ICH-GCP guidelines, making the training relevant for Canadian job roles.
Yes, UK-based students from London, Manchester, Birmingham, Leeds, and Glasgow can enroll in this online course. The curriculum covers MHRA, EU EMA, and UK regulatory standards, making it ideal for jobs in the UK clinical trials industry.
Meet Aarthi P, a student of our Advanced Diploma in Clinical Research (ADCR) at BCRI. Even before completing the course, she landed a job at ICON PLC Clinical Research—a proud moment for her and for us!
In this short video, Aarthi shares how BCRI’s live online classes, practical training, and career support helped her achieve her dream job in the clinical research industry.
📢 Why Students Choose BCRI:
✔ Job-focused training with real-world projects
✔ Expert guidance from experienced faculty
✔ Internship and placement support that delivers results
Address: 19/19 Chandrodaya Complex, 2nd Floor, 24th Main, Agara Sector 1, HSR Layout, Bangalore, KA 560102, India.
Ph: +91 9403890582
Email: [email protected]
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Our Team would love to Guide you to select the right course here .
