OVERVIEW

Real-world submission preparation, eCTD assembly, and global regulatory strategy

Available in two formats: 3-Month Accelerator | 6-Month Deep Dive

Fully online. Self-paced. Start immediately.

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This program trains you to prepare regulatory submissions, manage eCTD dossiers, navigate global compliance frameworks, and execute regulatory affairs operations the way they're actually practiced in pharmaceutical companies, medical device firms, and regulatory consulting organizations worldwide.

You'll work inside simulated regulatory environments where you handle real submission scenarios, use industry-standard tools, and execute regulatory strategies under realistic timelines. By the end, you can demonstrate documented competence in the core functions pharmaceutical regulatory affairs departments need from day one.

What You'll Actually Learn.

Foundations of Regulatory Affairs

You start with the regulatory landscape: understanding what regulatory affairs is, global regulatory bodies (FDA, EMA, CDSCO), drug development and regulatory pathways, CTD (Common Technical Document) and eCTD structures, Good Manufacturing Practices (GMP) basics, AI applications in regulatory research, regulatory documentation essentials, ethics in regulatory affairs, regulatory terminology and acronyms, and introduction to the ZANE Omega Regulatory Affairs Lab.

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eCTD and Submission Systems

You'll master electronic submission architecture: eCTD overview and module architecture, Module 1 (Administrative Information), Module 2 (Summaries and Overviews), Module 3 (Quality/CMC fundamentals), Module 4 (Nonclinical Study Reports), Module 5 (Clinical Study Reports), AI-assisted eCTD assembly, version control in regulatory submissions, eCTD validation and technical checks, and submission software systems (frevvo, Extedo platforms).

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Global Regulatory Frameworks

You'll navigate international regulatory systems: FDA regulatory framework, EMA and European Union regulations, CDSCO and Indian regulatory system, TGA and Australian compliance, ICH guidelines and harmonization, AI-based cross-country regulatory comparison, regional submission timelines, regulatory strategy fundamentals, multi-country filing management, and common regulatory pitfalls and errors.

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Regulatory Writing and Communication

You'll develop professional regulatory writing skills: principles of regulatory writing, submission cover letters, SmPC (Summary of Product Characteristics) and labeling summaries, responses to regulatory queries, AI-assisted document editing, KOL (Key Opinion Leader) and stakeholder communication, handling objections and deficiencies, regulatory document formatting standards, version control in regulatory writing, and data presentation for regulatory review.

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Chemistry, Manufacturing and Controls (CMC)

You'll compile quality documentation: CMC module overview, drug substance specifications, drug product manufacturing processes, quality control testing requirements, stability studies and data interpretation, AI-driven CMC gap analysis, batch record documentation, impurity profiles and safety assessment, CMC amendments and variations, and CMC requirements for biologics versus small molecules.

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Labeling and Packaging Compliance

You'll ensure compliant product information: global labeling regulations, USPI (US Prescribing Information) and EU SmPC requirements, packaging compliance fundamentals, serialization and traceability, AI-based labeling harmonization, Patient Information Leaflets (PIL), labeling deviation management, artwork review processes, multi-language labeling, and labeling change control.

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Submission Lifecycle Management

You'll manage the complete submission process: pre-submission planning, IND (Investigational New Drug) and CTA (Clinical Trial Application) submission preparation, NDA (New Drug Application) and BLA (Biologics License Application) submission structure, post-submission query handling, AI-based submission tracking, variation filings (Type IA, IB, II), annual reports and PSURs, renewal submissions, post-approval commitments, and submission lifecycle audit trails.

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Regulatory Audits and Inspections

You'll prepare for and respond to regulatory oversight: regulatory audits and inspection types, FDA inspection preparation, EMA inspection expectations, CAPA (Corrective and Preventive Actions) for audit findings, AI-based audit trail validation, mock regulatory audit simulations, handling inspector queries, document control for audits, post-audit reporting, and continuous compliance monitoring.

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Medical Device Regulations

You'll understand device-specific regulatory pathways: medical device regulatory landscape, 510(k) and PMA (Premarket Approval) pathways, EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) frameworks, AI-assisted device submission preparation, risk management under ISO 14971, UDI (Unique Device Identification) and device labeling, post-market surveillance for devices, clinical evaluation reports, change control for medical devices, and global device regulatory harmonization.

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Regulatory Intelligence and Strategy

You'll develop strategic regulatory capabilities: regulatory intelligence sources, tracking regulatory trends, competitor intelligence in regulatory affairs, AI-based policy forecasting, strategic submission planning, KOL and advisory board engagement, regulatory risk assessment, cross-functional regulatory strategy, budgeting for regulatory submissions, and global regulatory portfolio management.

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Advanced AI Applications in Regulatory Affairs

You'll integrate intelligent systems into regulatory operations: automated dossier assembly, NLP-based regulatory query analysis, predictive analytics for submission outcomes, AI-driven labeling automation, blockchain for submission integrity, AI ethics and bias in regulatory affairs, real-world evidence in regulatory submissions, AI-based variation management, future trends in regulatory affairs, and AI integration with regulatory systems.

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Capstone Integration and Career Preparation

You'll complete the full regulatory lifecycle through advanced simulations: end-to-end regulatory lifecycle review, advanced regulatory simulation strategies, portfolio development for regulatory roles, interview preparation for regulatory affairs positions, professional networking in regulatory affairs, AI-driven career planning, case studies of successful submissions, managing submission rejections, emerging regulations and policy shifts, and final regulatory affairs capstone simulation.

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Systems You'll Use

Training includes hands-on work with the tools and systems used in regulatory affairs operations:

• eCTD assembly and viewing platforms (frevvo, Extedo simulations)

• Regulatory submission tracking systems

• Document management and version control tools

• Global regulatory databases (Drugs@FDA, EMA Portal, CDSCO)

• AI-assisted dossier assembly tools

• Labeling harmonization and compliance checkers

• Packaging artwork review systems

• Regulatory calendar and deadline management platforms

• CMC gap analysis and validation tools

• Submission validation and technical check software

• NLP systems for regulatory query analysis

• Predictive analytics for submission outcomes

AI tools are integrated throughout—you'll learn to use them for automated document assembly, gap detection, and regulatory intelligence gathering. This mirrors how modern regulatory affairs professionals actually work.

Career Outcomes

Graduates are prepared for these regulatory affairs roles:

• Regulatory Affairs Associate

• Global Submission Coordinator

• Labeling & Packaging Compliance Analyst

• Dossier & eCTD Specialist

• Regulatory Operations Executive

• CMC Documentation Officer

• Regulatory Intelligence Analyst

• Regulatory Strategy Associate

• Medical Device Regulatory Specialist

• Post-Marketing Compliance Coordinator

Pharmaceutical companies, medical device manufacturers, biotechnology firms, and regulatory consulting organizations actively recruit candidates with documented regulatory affairs competencies. This training provides that documentation.

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Ready to start? Enroll now and begin immediately.