Online Diploma in Regulatory Affairs in Pharmaceuticals - Univista EdTech
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Course Overview
The Online Diploma in Regulatory Affairs in Pharmaceuticals by Univista EdTech is an advanced professional program that prepares learners to navigate the complex global regulatory landscape governing the development, approval, manufacturing, and marketing of pharmaceutical products.
This course provides a deep understanding of regulatory frameworks, submission processes, documentation standards, and compliance practices across major health authorities such as USFDA, EMA, MHRA, WHO, and CDSCO.
It bridges the gap between scientific innovation and regulatory compliance, enabling learners to ensure that pharmaceutical products meet the highest standards of safety, efficacy, and quality before reaching patients worldwide.
15 Months
INR 1,00,000
Intake: Year around admissions
Key Highlights
Comprehensive curriculum covering global regulatory guidelines and submission pathways.
Learn directly from regulatory professionals, pharmacists, and compliance experts.
Practical exposure to drug registration, dossier compilation, and submission management.
Study ICH, GxP, and pharmacovigilance frameworks in real-world contexts.
Capstone project focused on a regulatory submission or market authorization plan.
Focus on global harmonization, ethics, and lifecycle management of pharmaceuticals.
Ideal for students and professionals in pharmacy, life sciences, biotechnology, or clinical research.
Skills You Will Learn
Understanding of global drug laws, regulatory pathways, and frameworks.
Dossier preparation and submission (CTD, eCTD, ACTD formats).
Regulatory documentation, compliance, and variation management.
Drug approval processes across regions – USA, EU, India, Japan, and emerging markets.
Good Regulatory Practice (GRP) and Quality Management integration.
Labeling, packaging, and promotional material compliance.
Post-approval changes, renewals, and lifecycle maintenance.
Communication and coordination with regulatory agencies.
Tools You’ll Master
Course Outcomes
- Gain complete knowledge of the global pharmaceutical regulatory environment.
- Develop and compile regulatory submissions for new drugs, generics, and biologics.
- Understand the principles of GxP, clinical trial regulations, and pharmacovigilance.
- Apply knowledge to manage compliance, audits, and inspections effectively.
- Prepare for regulatory roles in pharma, biotech, CROs, or consulting organizations.
Learning Outcomes
- By completing this diploma, learners will be able to:
- Interpret and apply international pharmaceutical regulatory guidelines.
- Prepare and review documentation for drug approvals and post-approval changes.
- Manage product registrations and maintain regulatory compliance across markets.
- Understand lifecycle management of pharmaceutical products.
- Communicate effectively with regulatory agencies and internal stakeholders.
Key Outcomes
- Professional certification in Regulatory Affairs in Pharmaceuticals from Univista EdTech.
- Portfolio of practical regulatory projects including submission case studies and dossier reviews.
- Job readiness for roles such as Regulatory Affairs Associate, Compliance Officer, Drug Registration Executive, or Pharmacovigilance Specialist.
- Career advantage in global and domestic pharmaceutical markets.
- Foundation for higher studies or professional advancement in Regulatory Sciences and Quality Management.
Course Curriculum
Module 1
Introduction to Pharmaceutical Regulatory Affairs
Module 2
Global Regulatory Frameworks – USFDA, EMA, MHRA, WHO, CDSCO
Module 3
Drug Development Process & Regulatory Documentation
Module 4
Dossier Compilation – CTD, eCTD, ACTD Formats
Module 5
Clinical Trial Regulations and Good Regulatory Practices (GRP)
Module 6
Labeling, Packaging, and Promotional Compliance
Module 7
Pharmacovigilance and Post-Marketing Surveillance
Module 8
Regulatory Submissions, Audits, and Inspections
Module 9
Lifecycle Management and Product Variations
Module 10
Capstone Project – Market Authorization Dossier for a Pharmaceutical Product
Why You Should Join this Course
- Global Relevance: Understand regulations that govern the world’s top pharmaceutical markets.
- Career-Driven Learning: Gain skills in high demand across regulatory, QA, and clinical research domains.
- Industry Mentorship: Learn directly from seasoned regulatory professionals and auditors.
- Practical Application: Develop real-world dossiers, audit checklists, and compliance frameworks.
- Multi-Sector Career Path: Opportunities in pharma, biotech, medical devices, and CROs.
- Powered by Univista EdTech: A platform committed to futuristic, technology-driven, and employability-focused learning that empowers professionals to ensure regulatory excellence and patient safety across the global healthcare ecosystem.
₹1,00,000
Admissions Open
Eligibility
- Minimum Qualification: 10+2 (High School) or equivalent
- Open to graduates, working professionals, and entrepreneurs
Admission Criteria
- Online application submission
- Document verification (education + ID proof)
- Admission confirmation after fee payment
