Global Regulatory Affairs Hands-on Training Program with LIVE Project Work - Admissions Open
Global Regulatory Affairs
Hands-On Training + Real-Time Project Work
From Life Science Graduate to Global Regulatory Affairs Professional — Build the Skills That Leading Pharma Companies Look For.
Fast-track your career with expert-led training, practical regulatory affairs workflows, and real-time project experience, designed for Life Science, Pharma and Chemistry graduates.
LAST BATCH OF THE YEAR
Where Can Regulatory Affairs Skills Take You?
Regulatory Affairs professionals support the pharmaceutical industry by helping organizations navigate regulatory requirements, submissions, compliance and product approvals. Build skills relevant to careers across global pharmaceutical companies, biotechnology organizations, consulting firms and CROs.
"The pharmaceutical industry needs more than scientific knowledge. It needs professionals who understand global regulatory standards, compliance, and the journey from drug development to market approval. Build the skills to become one of them."
Company names are illustrative examples of organizations in the broader pharmaceutical and regulatory affairs industry. They do not represent guaranteed employment, direct recruitment arrangements, or confirmed Biotecnika placement partnerships.
If you are looking to build a strong foundation and gain real-world expertise in Global Regulatory Affairs, this comprehensive program is your ideal choice. Designed to take you from fundamental concepts to hands-on project work, this course provides practical exposure to regulatory submissions, compliance strategies, and dossier preparation. By the end of the training, you’ll be equipped with the technical knowledge and practical experience needed to excel in this highly regulated and competitive industry.
Program Details:
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Batch Starts: 18th NOV 2026
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Course Duration: 45 Days with 15 Days, 1 month & 3 months Project
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Get Recording (for revision and in case you miss the class) + LIVE Class Access
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Timings: 9:00 PM - 10:00 PM IST
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Venue: Online
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100% Placement Assistance by the Biotecnika Placement Team
MEET YOUR INSTRUCTORS
Dr. Vaishnavi Babu
PhD in Biotechnology | Pharmaceutical Quality, GMP & Regulatory Compliance | Scientific Trainer at Biotecnika
Dr. Vaishnavi Babu holds a Ph.D. in Biotechnology and brings 14+ years of experience 
in pharmaceutical production, quality assurance, quality control, GMP compliance, regulatory documentation, and scientific training. She has worked extensively across OSD and biologics manufacturing, with strong expertise in specification documentation, SOP management, data integrity, technology transfer, regulatory audits, risk assessment, and cross-functional quality systems.
She has led compliance and learning operations in GMP-regulated environments at reputed organizations such as Apotex and Kemwell, supporting pharmaceutical manufacturing, quality operations, analytical compliance, microbiology, and QC training enablement. She is also associated with Scientific Training at BioTecNika, where she contributes to industry-oriented learning and skill development for life science and pharmaceutical professionals.
With a strong background in research, scientific writing, microbiology, and quality management, she has multiple peer-reviewed publications and hands-on industry experience in the pharmaceutical and biotechnology sectors. Her practical exposure to GMP systems, regulatory expectations, audit readiness, quality documentation, and scientific training makes her a valuable mentor for learners pursuing careers in Global Regulatory Affairs, Quality Assurance, Quality Control, Pharmaceutical Compliance, and Biotechnology-based industry roles.
Bhoomika Soumya Sindhu V.M.
Clinical Data Management & Regulatory Affairs Expert | Industry Professional & Trainer
Bhoomika Soumya Sindhu V.M. is an accomplished Clinical Data Management professional with over 4 years of 
hands-on industry experience across leading global organizations, including **Labcorp, Accenture, and Eurofins.
She brings extensive expertise in Electronic Data Capture (EDC) systems, including Medidata RAVE and Oracle InForm, User Acceptance Testing (UAT), Query Management, and Database Lock processes, with a strong focus on GCP and cGMP compliance.
Having led and trained UAT teams on new EDC systems, she possesses valuable experience in clinical data operations, system validation, and quality-driven workflows. She combines real-world industry insights with practical technical expertise to equip aspiring professionals with the skills and confidence required to succeed in the Clinical Data Management industry.
What Will You Learn?
Download Curriculum
Induction Session
Pre-Course Assessment
Module I: Introduction & Overview of Global Regulatory Frameworks
Session 1: Fundamentals of Regulatory Affairs
Session 2: Overview of Global Regulatory Agencies (FDA, EMA, MHRA, TGA, CDSCO, PMDA)
Session 3: Harmonisation Initiatives
Session 4: GxP Ecosystem Overview
Session 5: Clinical Trial Approval Process (Global Perspective)
Session 6: LIVE Q&A / Mock Interview
Module I Assessment / Activity
Module II: Drug / Biologics: Global Regulatory Submissions & Documentation
Sessions 7-8: Drug Development Lifecycle (Preclinical, Clinical, Post-market)
Session 9: Investigational Pathways (US IND & EU CTA)
Session 10: The CTD & eCTD Architecture (Modules 1 & 2)
Session 11: CTD Module 3: CMC Deep Dive (Part 1, Drug Substance)
Session 12: CTD Module 3: CMC Deep Dive (Part 2, Drug Product)
Session 13: CTD Module 4 (Non-Clinical) & Module 5 (Clinical)
Session 14: NDA (New Drug Application) (FDA)
Sessions 15-16: ANDA (Abbreviated New Drug Application) for Generics
Session 17: MAA (Marketing Authorisation Application) (EMA)
Session 18: Biologics & Biosimilars Pathways
Session 19: LIVE Q&A / Mock Interview
Module II Assignment
Module III: Medical Devices and Combination Products: Global Regulatory Submissions & Documentation
Session 20: Global Medical Device Classification
Session 21: US Device Pathways
Session 22: EU MDR (2017/745) & IVDR (2017/746)
Session 23: Device Quality Systems
Session 24: Risk Management & Biocompatibility
Session 25: Combination Products: Regulatory Pathways and Submission
Session 26: LIVE Q&A / Mock Interview
Module III Assignment
Module IV: Clinical Trial Regulations & Compliance
Session 27: Ethical Considerations and IRB/IEC Submission
Session 28: Clinical Trial Data Privacy & Integrity
Session 29: Clinical Trial Protocol & Documents: Hands-on Protocol Preparation
Session 30: LIVE Q&A / Mock Interview
Module IV Assessment / Activity
Module V: Regulatory Strategy & Post-Market Requirements
Session 31: Labelling, Artwork & Promotions
Session 32: Post-Market Safety: Drugs & Biologics
Session 33: Post-Market Safety: Medical Devices
Session 34: Post-Approval Lifecycle
Session 35: LIVE Q&A / Mock Interview
Module V Assignment
Module VI: Regulatory Document Preparation & Review
Session 36: Quality Agreements & Vendor Oversight
Session 37: Regulatory Inspections & Readiness
Session 38: Audit Trail & CAPA Systems
Session 39: Hands-on Deficiency Handling
Session 40: LIVE Q&A / Mock Interview
Module VI Assessment / Activity
Module VII: Use of Software and AI, Case Study, Industry Collaboration & Career Path
Session 41: Use of Software Platforms and Advent of AI in Regulatory Affairs
Session 42: Document Review with Practical Industry Insights
Session 43: Real-life Case Studies and Working with Manufacturers
Session 44: Career Opportunities in GRA: Stakeholders, Roles, Salary Trends & Pathways
Session 45: Professional Resume Strategy Session
Session 46: Final Doubt Solving Session
Final Course Assessment
Module VIII: Project Preparation, Formats and Templates
Project Orientation (15 Days, 1 Month & 3 Months)
Mid Project Discussions
Student’s Project Report Submission, Presentation & Mock Regulatory Agency Review Panel
REGULATORY AFFAIRS PROJECT LIST
15-Day Project List
- Role of ICH Guidelines in Global Drug Regulation with Real World Examples
- Lifecycle Management of a Drug Product: Regulatory Perspective
- Regulatory Strategy for Filing a Generic Drug (ANDA Process)
- Impact of Brexit on Drug Regulatory Submissions in the UK and EU
- Benefit-Risk Assessment for a Legacy Medical Device
- Benefit-Risk Framework for a Simple Biologic
- Labelling Comparison for Biologics across FDA and EMA-Approved Biologics
1-Month Project List
- Role of ICH Guidelines in Global Drug Regulation with Real World Examples
- Lifecycle Management of a Drug Product: Regulatory Perspective
- Regulatory Strategy for Filing a Generic Drug (ANDA Process)
- Labelling and Packaging Regulations in Major Markets with Real World Examples
- Impact of Brexit on Drug Regulatory Submissions in the UK and EU
- Benefit-Risk Assessment for a Legacy Medical Device
- Requirements Comparison: India Schedule Y vs ICH CMC (aligning Indian Schedule Y biologics requirements with ICH M4Q guidelines)
- Benefit-Risk Framework for a Simple Biologic
- Labelling Comparison for Biologics across FDA and EMA-Approved Biologics
- Risk Assessment for a Hypothetical Insulin Pump
- Labelling Compliance Case Study: Contact Lens in the EU Market
3-Month Project List
- Detailed Process for Registering Drugs, Cosmetics and Medical Devices in EMA
Deliverables: EMA framework in detail; presentation explaining the registration process; drug registration in Australia; documentation for product and cosmetics registration; process to obtain CE certification. - Comparative Study of Regulatory Approval Processes: US FDA vs EMA
Deliverables: Regulated goods under FDA and EMA; approval processes as flow charts; summarised guide to key differences and similarities. - Drug Master File (DMF): Structure, Submission & Global Requirements
Deliverables: Template or checklist for compiling a DMF (US, EU and India). - Documentation for Clinical Trials: IND vs CTA
Deliverables: Checklist for clinical trial submissions in both the US and the EU. - Dossier Preparation: CTD vs eCTD Format
Deliverables: Sample Module 1 and Module 2 outline for a hypothetical drug. - Regulatory Requirements for Herbal or Traditional Medicines
Deliverables: Overview table of global herbal drug regulations (India AYUSH, EU Traditional Use Registration, US DSHEA). - ISO 13485 Surveillance Audit vs FDA QSR Inspection: A Comparative Mock Audit for ImmuneMab Therapeutics
Deliverables: Two mock audit reports (ISO and FDA style); comparison matrix of ISO clauses vs 21 CFR 820 sections; discussion on regulatory harmonisation and risk. - CE-Marking Technical File for a Legacy Medical Device
Deliverables: Classification justification under EU MDR; design dossier with clinical evaluation and risk management (ISO 14971); labelling and IFU for EU and US; FDA vs EU gap analysis; final slide presentation. - Checklist for Global IND/NDA/BLA Submissions
Deliverables: Side-by-side CTD module checklist for US, EU and India; annotated key requirement explanations; presentation on major differences. - Post-Market Surveillance Strategy for a Wearable Device
Deliverables: EU MDR-compliant surveillance plan (metrics, frequency, data collection); SOP template for adverse event reporting; flow diagram for escalation and corrective action. - AI Tools to Accelerate CTD Authoring and Document Review (Only for experienced candidates)
Deliverables: CTD checklist, regulatory reference list and AI prompt library; sample CTD documents and document review checklist; comparison report, final project report and presentation.
Frequently asked questions
Are these going to be live sessions?
The Internship will have online live interactive sessions + recorded sessions, and assignments will be given. Our expert will be available to guide you throughout the course.
What If I miss a session?
The recording of the sessions will be available for the duration of internship & project work. So you can go back and refer to the recordings, but make sure you do not miss the live sessions and take maximum benefit from them.
Will I need to install any software?
The course does not require any additional software. However, if any requirement arises, the instructor will intimate it before the sessions.
Whom do I contact for any further queries or technical difficulties?
Have any trouble? Get in touch with our team. Click on that Chat thingy or write to us at cst@biotecnika.org or info@biotecnika.org