Regulatory Affairs Training

Specialized Training in Global Regulatory Standards (FDA, EMA, ICH-GCP) for Clinical and Pharma Submissions.

Enroll in the essential Regulatory Affairs course at Stansys. This program focuses on documentation & compliance—the critical process of navigating global guidelines to ensure pharmaceutical and clinical products are legal for marketing. We prepare you to handle submissions and maintain compliance, making you an employable, industry-ready professional in this high-responsibility domain.

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Yrs. of Excellence

Branches in HYD

Students Trained

Batches Trained

Why Regulatory Affairs is Key to Global Pharma Success

Regulatory Affairs (RA) professionals are the bridge between a company and global regulatory authorities. Mastering RA is crucial for timely product approval and maintaining compliance throughout the product lifecycle.

This course provides deep knowledge of guidelines from bodies like the FDA, EMA, and ICH-GCP, ensuring your expertise is recognized globally.

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High-Demand Roles

Regulatory Affairs Associate/Executive, Documentation Specialist, Submission Manager, Compliance Officer.

Domain Alignment

Works closely with Pharmacovigilance and Clinical Data Management (CDM) teams.

Secure Path

Essential, stable, and highly specialized career in pharmaceutical companies, CROs, and consulting firms.

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Pre-Requisites for Regulatory Affairs

Eligibility

Core Degrees:

B.Pharm, M.Pharm, B.Sc., M.Sc. (Life Sciences/Chemistry).

Technical Degrees:

B.Tech / B.E (any branch), MCA, BCA, B.Sc. (with a strong interest in documentation and legal compliance).

Domain Knowledge:

Excellent organizational and communication skills, with an interest in regulatory policies and high-standard documentation.

Who Can Attempt This Course?

Students and professionals seeking a career in the high-compliance side of the clinical and pharma industries.

Graduates looking for a specialized role that involves interpreting and applying global regulations.

Individuals interested in Summer Training/Internship programs focused on regulatory submission dossiers.

Detailed Regulatory Affairs Curriculum

This program covers the comprehensive life cycle of regulatory submissions and compliance, focusing heavily on the procedural and documentation requirements of major global agencies.

Introduction to Global Regulatory Agencies
Understanding the structure and function of the FDA (US), EMA (Europe), and the framework of the ICH-GCP guidelines.
Drug Development & Submission Process
Stages of drug development, IND/NDA/ANDA applications, and pre-clinical and clinical trial regulatory requirements.
Dossier Preparation & Format
Mastering the technical content and structure of regulatory documents, including the Common Technical Document (CTD) and eCTD.
Post-Marketing Compliance
Regulatory maintenance, variations and renewals, advertising regulations, and managing communication with regulatory bodies.
Audits & Inspections
Preparation for regulatory audits, managing compliance, and ensuring ethical practices in line with ICH-GCP.

Why Choose Stansys?

Our Unmatched Commitment to Your Success

100% Job Assistance

We are committed to providing 100% Job Assistance upon successful completion of your training.

Expert Instructors

Learn from our Expert Instructors through live classes, supported by 24 X 7 Support.

Real-Time Project Training

We will train you on real-time projects using real-time data to help you gain real-time industry knowledge.

Industry-Focused Training

We provide an unmatched environment that keeps the balance between theoretical knowledge and real-world experience.

Flexible Learning

Benefit from our flexible schedule and choose from Classroom or On-line Training solutions tailored to your needs.

Mobile Learning Access

Manage your courses, access materials, and utilize support instantly via the official Stansys app on Android and iOS.

Frequently Asked Questions (FAQs)

What is the main focus of a Regulatory Affairs professional?
The main focus is to ensure that all products meet the legal and ethical requirements of the global health authorities and to manage the high-quality documentation required for product registration.
What is the significance of ICH-GCP, FDA, and EMA in this course?
These bodies set the gold standard for documentation & compliance. Our course is structured around their guidelines to ensure your knowledge is immediately applicable to any global pharma or clinical company.
Does Stansys cover the technical aspects of submission, like eCTD?
Yes, we cover the structure and requirements of the electronic Common Technical Document (eCTD) to ensure you understand the digital requirements for submission.
What is Stansys's approach to job placement in Regulatory Affairs?
We provide 100% Job Assistance, offering specialized resume crafting, mock interviews focusing on regulatory knowledge, and access to our network of partners in the compliance and consulting sectors.
Are the classes conducted online or in a classroom?
We offer flexible options: engaging Live Classes through our Classroom Training in our centers, or convenient On-line Training solutions to suit your flexible schedule.
What kind of support is available outside of class hours?
Students benefit from continuous 24 X 7 Support from our team to assist with complex compliance case studies, ensuring a thorough grasp of the procedural aspects.

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Regulatory Affairs Training