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 - 1st APRIL 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:
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Batch Starts: 1st April 2025
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Course Duration: 45 Days
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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
What Will You Learn?
Curriculum
Week 1-2: Introduction & Global Regulatory Frameworks
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Fundamentals of Regulatory Affairs
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Overview of global regulatory agencies (FDA, EMA, MHRA, TGA, CDSCO, PMDA)
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ICH guidelines and their importance
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Drug development lifecycle (Preclinical, Clinical, Post-market)
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Roles and responsibilities of regulatory professionals
Week 3: Regulatory Submissions & Documentation
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IND (Investigational New Drug) & NDA (New Drug Application) (FDA)
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MAA (Marketing Authorization Application) (EMA)
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ANDA (Abbreviated New Drug Application) for generics
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CMC (Chemistry, Manufacturing, and Controls) documentation
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Hands-on CTD/eCTD dossier preparation
Week 4: Clinical Trial Regulations & Compliance
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Clinical trial approval process (Global perspective)
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GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice)
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Ethical considerations and IRB/IEC submission
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Adverse event reporting & pharmacovigilance
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Hands-on: Preparing a clinical trial protocol
Week 5: Regulatory Strategy & Post-Market Requirements
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Labeling, advertising, and promotional regulations
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Post-marketing surveillance & pharmacovigilance
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Medical devices & combination product regulations
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Hands-on Assignment: Labeling, Brochure, and IFU Preparation
Week 6: Regulatory Document Preparation & Review
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Audit trail report, critical subcontractor quality agreement, and ISO certification
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Risk management files and biological evaluation files
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Post-marketing surveillance files, PSUR, and PMCF files
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Hands-on document review
Week 7: Case Study & Industry Collaboration
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Real-life case studies and working with manufacturers
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Document review with practical industry insights
Week 8: Project Preparation & Tool Training
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Hands-on project submission for approval
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Query mail preparation to manufacturers
Final Week: Project & Certification
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Real-world case studies and regulatory strategy formulation
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Capstone Project: Students work on a regulatory submission dossier
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Mock regulatory agency review panel (students present their submissions)
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Final assessment & certification
Regulatory Submission Dossier Preparation & Review
Project Title: Regulatory Submission Dossier for Device Approval – A Real-World Simulation
Objective:
Participants will work in teams (or individually) to prepare a regulatory submission dossier for a selected pharmaceutical, biologic, or medical device, following international regulatory guidelines (e.g., SFDA, EMA, CDSCO, PMDA, MHRA, TGA). The project will be evaluated through a mock regulatory agency review.
Project Structure:
Step 1: Product Selection & Regulatory Pathway Identification
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Choose a pharmaceutical drug, biologic, or medical device for submission
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Identify the appropriate regulatory agency (FDA, EMA, CDSCO, etc.) and submission pathway
Step 2: Preparing the Dossier
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Each team will compile a regulatory dossier using the Common Technical Document (CTD) / eCTD format.
Step 3: Submission & Mock Review
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Submit the dossier in CTD/eCTD format
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Conduct an internal peer review (teams will review and provide feedback on each other’s dossiers)
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Prepare a Regulatory Strategy Report outlining:
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Justification for approval
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Risk mitigation strategies
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Post-marketing commitments
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Step 4: Mock Regulatory Panel Review & Approval Decision
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Participants will present their submissions in a mock regulatory panel review
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Panel (trainers & selected participants) will ask questions & challenge justifications
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Based on responses, dossiers will be approved, conditionally approved, or rejected, with feedback
Evaluation Criteria:
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Completeness & Accuracy of the CTD/eCTD dossier
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Clarity & Justification in Regulatory Strategy
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Response to Regulatory Panel Questions
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Team Collaboration & Presentation Quality
Project Outcome & Certification
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Participants will receive a Regulatory Affairs Certification upon successful completion.
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Outstanding projects may be featured as case studies for future training
Meet Your Trainer
Shweta Birajdar
Regulatory Affairs & Clinical Data Management Scientist at Biotecnika Worked at TCS, Aston Carter, and EVERSANA
Shweta Birajdar is an industry expert in regulatory affairs, clinical data management, and drug safety, with extensive experience in compliance, regulatory submissions, and quality assurance. Her expertise spans across regulatory documentation, dossier preparation, and compliance with global regulatory frameworks, making her an ideal mentor for this program.
Her vast industry experience includes roles as:
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Regulatory Affairs Specialist Manager at Regulatory Standards, Jeddah – Led a team of 29 regulatory associates, ensuring compliance with SFDA regulations.
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Senior Analyst at EVERSANA – Worked on pharmaceutical market research and data analysis.
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Regulatory Reporting Specialist at Aston Carter – Focused on automating and scheduling regulatory reports.
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Clinical Data Management Specialist at Tata Consultancy Services (TCS) – Developed and delivered training programs on GCP, data validation, and regulatory reporting.
Shweta’s expertise and hands-on approach will equip participants with the skills needed to excel in the regulatory affairs domain.
Check the Course Curriculum & Project Details Below:
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
