Course offered by Rudra Education

Program Overview

The Advanced Diploma in Drug Regulatory Affairs (ADDRA) is a career-oriented program designed to prepare professionals for roles in the pharmaceutical and healthcare regulatory industry. The curriculum provides an in-depth understanding of global regulatory frameworks, drug approval processes, documentation, and compliance.

Ideal for life science graduates or pharmaceutical professionals, this program is delivered entirely online, with a focus on industry-relevant content and practical regulatory training.

 

Key Program Features

A regulatory-focused diploma tailored for pharma professionals.

Core Modules Include:

• Introduction to Drug Regulatory Affairs
   
• Global Regulatory Guidelines (USFDA, EMA, CDSCO, WHO)
   
• Drug Approval and Clinical Trial Procedures
   
• Regulatory Documentation and Dossier Preparation
   
• Intellectual Property Rights and Pharma Law
   
• Quality Assurance and GMP Compliance
   
• Pharmacovigilance and Post-Marketing Surveillance
   
• 100% online content with interactive assignments and projects
   
• Access to global case studies and current regulatory frameworks
   
• Training in submission management and technical writing
   

 

Program Highlights

• Covers the entire regulatory lifecycle from R&D to marketing
   
• Exposure to global and regional drug policies
   
• Ideal for career transitions into regulatory, QA, or clinical roles
   
• Includes dossier simulation and audit preparation
   

 

Eligibility Criteria

Applicants must:

• Hold a bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related fields
   
• Have a basic understanding of the drug development process
   

 

Program Duration

This diploma program is completed in 1 year, with industry-integrated content and case-based learning.

Career Opportunities

Graduates can work in roles such as:

• Regulatory Affairs Executive
   
• Drug Compliance Specialist
   
• Dossier Preparation Associate
   
• QA and Pharmacovigilance Associate
   
• Regulatory Auditor