Global Regulatory Affairs Hands-on Training Program with Project Work - Admissions Open

Global Regulatory Affairs Hands-on Training Program with REAL-TIME Project Work

Fast-Track Your Career in Regulatory Affairs With Expert-Led Training, Hands-On Experience, and Live Projects

100% Placement Assistance by the Biotecnika Placement Team

ADMISSIONS OPEN

NEW BATCH STARTS - 21st NOV 2025

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:

• Batch Starts: 21st Nov 2025

• Course Duration: 30 Days with 15 Days, 1 month & 3 months Project

• Get Recording (for revision and in case you miss the class) + LIVE Class Access

• Timings: 9:00 PM - 10:00 PM IST

• Venue: Online

• 100% Placement Assistance by the Biotecnika Placement Team

MEET YOUR INSTRUCTORS

Bhanu Melvin
Scientist & Trainer – Clinical Data Management, Pharmacovigilance & Regulatory Affairs @ Biotecnika
Former Regulatory Affairs Officer – Trucare Group of Companies, United Arab Emirates

With a robust academic background in pharmacy and over a decade of diverse experience spanning academia, healthcare, regulatory affairs, and corporate training, Bhanu Melvin brings a comprehensive and practical approach to professional skill development.

She has successfully trained 1,500+ learners — from academic aspirants to industry professionals — in critical domains including:

• Clinical Research

• Pharmacovigilance

• Clinical Data Management

• Regulatory Affairs

• Clinical SAS Programming

Bhanu holds prestigious global certifications in:

• Pharmacovigilance

• Lean Six Sigma Black Belt

• Clinical Research

• Clinical SAS Programming

• ISO 9001:2015 Lead Auditing

Her multidisciplinary expertise enables her to seamlessly connect scientific knowledge with regulatory frameworks, ensuring students gain both theoretical insight and industry-ready skills. Passionate about empowering professionals, she specializes in designing skill-oriented curricula, enhancing compliance processes, and streamlining clinical workflows — preparing learners for success in the fast-evolving life sciences sector.

Dr. Ganeshan, Ph.D.
Scientific Expert – QA/QC & Global Regulatory Affairs @ Biotecnika
Former Clinical Director – Medical Electronic Systems India Pvt. Ltd.

Dr. Ganeshan holds a Ph.D. in Microbiology and brings extensive expertise across biosimilars, quality assurance, medical diagnostic laboratories, and medical devices. As the former Clinical Director at Medical Electronic Systems India Pvt. Ltd., he led research and development efforts that resulted in the creation of an advanced diagnostic kit for semen analysis.

With strong proficiency in clinical trials, data analysis, and regulatory affairs, Dr. Ganeshan has a proven track record of bridging research innovation with compliance excellence. His passion for teaching and continuous learning enables him to present complex scientific and regulatory concepts in an engaging, relatable manner, preparing learners for real-world challenges in the life sciences and regulatory domains.

What Will You Learn?

Curriculum

Induction Session

Week 1–2: Introduction & Global Regulatory Frameworks

• Day 1: Fundamentals of Regulatory Affairs

• Day 2: Overview of global regulatory agencies (FDA, EMA, MHRA, TGA, CDSCO, PMDA)

• Day 3: Clinical trial approval process (Global perspective)

• Day 4: ICH GCP

• Day 5: Drug development lifecycle (Preclinical, Clinical, Post-market)

• Day 6: Roles and responsibilities of regulatory professionals

• Assessment/Assignment for Week 1 & 2

Week 3: Regulatory Submissions & Documentation

• Day 7: IND (Investigational New Drug) & NDA (New Drug Application) (FDA)

• Day 8: MAA (Marketing Authorization Application) (EMA)

• Day 9: ANDA (Abbreviated New Drug Application) for generics

• Day 10: CMC (Chemistry, Manufacturing, and Controls) documentation

• Day 11: Hands-on CTD/eCTD dossier preparation

• Assessment/Assignment for Week 3

Week 4: Clinical Trial Regulations & Compliance

• Day 12: Clinical trial approval process (Global perspective)

• Day 13: GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice)

• Day 14: Ethical considerations and IRB/IEC submission

• Day 15: Adverse event reporting & pharmacovigilance

• Day 16: Hands-on: Preparing a clinical trial protocol

• Assessment/Assignment for Week 4

Week 5: Regulatory Strategy & Post-Market Requirements

• Day 17: Labeling, advertising, and promotional regulations

• Day 18: Post-marketing surveillance & pharmacovigilance

• Day 19: Medical devices & combination product regulations

• Day 20: Hands-on Assignment: Labeling, Brochure, and IFU Preparation

• Assessment/Assignment for Week 5

Week 6: Regulatory Document Preparation & Review

• Day 21: Audit trail report, critical subcontractor quality agreement, and ISO certification

• Day 22: Risk management files and biological evaluation files

• Day 23: Post-marketing surveillance files, PSUR, and PMCF files

• Day 24: Hands-on document review

• Assessment/Assignment for Week 6

Week 7: Case Study, Industry Collaboration & Career Path

• Day 25: Real-life case studies and working with manufacturers

• Day 26: Real-life case studies and working with manufacturers

• Day 27: Document review with practical industry insights

• Day 28: Career Opportunities in GRA: Stakeholders, Roles, Salary Trends & Pathways

• Day 29: Professional Resume Strategy Session

• Day 30: Live Q&A & Feedback

• Final Assessment

PROJECTS AVAILABLE

1-Month Project List

1. Role of ICH Guidelines in Global Drug Regulation

   • Objective: Study the impact of ICH guidelines (Q, S, E, M series) on regulatory submissions.

   • Deliverables: Report mapping major ICH guidelines to drug development stages.

2. Lifecycle Management of a Drug Product: Regulatory Perspective

   • Objective: Study variations, renewals, and post-approval changes across markets.

   • Deliverables: Flowchart of post-approval change classifications (Type IA, IB, II).

3. Regulatory Strategy for Filing a Generic Drug (ANDA Process)

   • Objective: Understand bioequivalence, patent certification (Paragraph IV), and labeling requirements.

   • Deliverables: Step-by-step ANDA filing strategy.

4. Labelling and Packaging Regulations in Major Markets

   • Objective: Study US, EU, and Indian labeling requirements including serialization and barcoding.

   • Deliverables: Label review checklist for regulatory compliance.

5. Impact of Brexit on Drug Regulatory Submissions in the UK and EU

   • Objective: Assess changes in submission procedures, licensing, and pharmacovigilance post-Brexit.

   • Deliverables: Timeline and strategy guide for navigating UK MHRA requirements.

6. Benefit–Risk Assessment for a Legacy Medical Device

   • Objective: Research submissions history (FDA 510(k), EU CE file) for a long-established device and develop a benefit–risk scoring framework compliant with EU MDR or IMDRF principles.

   • Deliverables: Benefit–risk scoring framework, labeling, clinical evaluation, post-market surveillance requirements, and risk management plan.

7. Requirements Comparison: India Schedule Y vs ICH CMC

   • Objective: Align Indian Schedule Y biologics requirements with ICH M4Q guidelines to develop cross-region regulatory compliance awareness.

   • Deliverables: Comparison grid of dossier contents, compliance checklist, and gap-mitigation recommendation memo.

8. Benefit–Risk Framework for a Simple Biologic

   • Objective: Design a benefit–risk scoring sheet per ICH and ISO 14971 for a known biologic.

   • Deliverables: Scoring matrix, mock clinical evaluation report, and summary presentation.

9. Labelling Comparison for Biologics

   • Objective: Explore differences in labeling across FDA and EMA-approved biologics.

   • Deliverables: Analysis of two real biologic labels, highlighted regional differences, and short regulatory context report.

10. Risk Assessment for a Hypothetical Insulin Pump

    • Objective: Apply ISO 14971 risk processes to evaluate a prototype insulin pump.

    • Deliverables: Hazard identification list, FMEA-based risk register, mitigation strategy matrix, and SOP for design changes.

11. Labelling Compliance Case Study: Contact Lens in UAE Market

    • Objective: Address unique regional labeling requirements for a UK device in the UAE without altering the global label.

    • Deliverables: Regulatory review, compliant packaging proposal, and mock localized label design.

3-Month Project List

1. Detailed Process for Registering Drugs, Cosmetics, and Medical Devices in EMA

   • Objective: Study regulated products under EMA, CE marking, certification, and documentation requirements.

   • Deliverables: Detailed EMA framework, presentation, Australian drug registration process, cosmetics registration process, and CE certification procedure.

2. Comparative Study of Regulatory Approval Processes: US FDA vs EMA

   • Objective: Compare drug approval pathways, timelines, and documentation requirements.

   • Deliverables: Regulated goods list, approval process flowcharts, and summarized comparison guide.

3. Drug Master File (DMF): Structure, Submission & Global Requirements

   • Objective: Explore types of DMFs and submission strategies for US, EU, and India.

   • Deliverables: DMF compilation template or checklist.

4. Documentation for Clinical Trials: IND vs CTA

   • Objective: Compare US IND and EU CTA requirements for clinical trial authorization.

   • Deliverables: Clinical trial submission checklist for both regions.

5. Dossier Preparation: CTD vs eCTD Format

   • Objective: Understand CTD and eCTD structures, modules, and technical requirements.

   • Deliverables: Sample Module 1 and Module 2 outlines for a hypothetical drug.

6. Regulatory Requirements for Herbal or Traditional Medicines

   • Objective: Investigate regulations in India (AYUSH), EU (Traditional Use Registration), and US (DSHEA).

   • Deliverables: Global herbal drug regulations overview table.

7. ISO 13485 Surveillance Audit vs FDA QSR Inspection: Comparative Mock Audit

   • Objective: Simulate both an ISO 13485 surveillance audit and an FDA inspection for a biologics manufacturer.

   • Deliverables: Two mock audit reports, comparison matrix, and harmonization discussion.

8. CE-Marking Technical File for a Legacy Medical Device

   • Objective: Create a CE technical file for an established Class II medical device and compare with EU MDR requirements.

   • Deliverables: Classification justification, design dossier, labeling, gap analysis, and strategy presentation.

9. Checklist for Global IND/NDA/BLA Submissions

   • Objective: Construct a beginner’s checklist comparing submission modules for US, EU, and India.

   • Deliverables: Submission checklist, annotated requirements, and comparison presentation.

10. Post-Market Surveillance Strategy for a Wearable Device

    • Objective: Develop an EU MDR-compliant post-market safety program for a wearable biosensor.

    • Deliverables: Surveillance plan, SOP template, and corrective action flow diagram.

DOWNLOAD the Course Curriculum & Project Details

Frequently asked questions

Are these going to be live sessions?

The Internship will combine live interactive sessions, offline & online + 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 five days post-completion of the internship. 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