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Job Ready Program

Regulatory Affairs Training Course in India

Job-Oriented Regulatory Affairs Course with Certification & Placement Support

Regulatory affairs training prepares professionals to ensure that pharmaceutical products, medical devices, and healthcare technologies comply with national and international regulatory requirements

₹11 LPA

Average Salary After Course

in

34000+

Pharmacovigilance Jobs Available

7+

Industry Expert Mentors

3,785 already upskilled!

Request A Callback

Fill your details and select a date for your live class

Our Learners Work at Top Companies

TCS syneos Health Quanticate Propharma Pfizer Innova Solutions Eversana Eli Lilly Corro health Continuum AtvigilX

Who can join this Pharmacovigilance Training?

MBBS

MBBS Graduates/
Doctors

BDS

BDS Graduates/
Dentists

BSc Nursing

BSc Nursing/
Nurses

BPT

BPT/
Physiotherapists

BAMS

BAMS Graduates/
Ayurveda Vaidya

BHMS

BHMS Graduates/
Homeopaths

BUMS

BUMS Graduates/
Hakeems

Biotechnology

BSc Biotechnology/
Biotechnologists

Microbiology

BSc Microbiology/
Microbiologists

Zoology

BSc Zoology/
Zoologists

Botany

BSc Botany/
Botanists

Be in the spotlight by getting certified!

Our industry-recognized certificate is valued by leading pharmaceutical companies worldwide. Stand out from the crowd with credentials that matter.

Certificate

Program Highlights

Explore what makes this mentorship program the best choice for your career in Regulatory Affairs.

Strong Regulatory Foundation from Industry Experts

Build conceptual clarity through structured regulatory affairs training delivered by professionals with real-world regulatory exposure and global industry experience.
  • Fundamentals of regulatory affairs and product lifecycle management
  • Global regulatory landscape and health authority expectations
  • Regulatory strategies for drugs, biologics, and medical devices
  • In-depth understanding of compliance, audits, and inspections
Regulatory Experts

Hands-On Regulatory Documentation & Submission Training

Gain practical exposure to the critical documents and submission processes used in leading global regulatory roles.
  • Master Dossier structures and CTD / eCTD compilation
  • Learn the end-to-end process of regulatory submissions and variations
  • Understand labeling, artwork management, and post-approval lifecycle
  • Develop skills in regulatory intelligence and change management
Documentation Training

AI-Enabled Regulatory Affairs Software Training

Stay ahead of the curve with India’s first AI-enabled regulatory affairs training ecosystem, focusing on automation and modern compliance tech.
  • Hands-on exposure to modern regulatory documentation tools
  • Use AI for assisted regulatory intelligence and document review
  • Implement automation concepts to streamline regulatory workflows
  • Learn data tracking and build real-time compliance dashboards
AI in Regulatory Affairs

Career Readiness & Placement Preparation

Bridge the gap between training and employment with personalized career support tailored for the Regulatory Affairs job market.
  • Craft ATS-friendly resumes optimized for Regulatory Affairs roles
  • Optimize your LinkedIn profile to attract top pharma recruiters
  • Participate in technical mock interviews and role-specific HR rounds
  • Master salary negotiation and professional communication for RA positions
Career Readiness

Tools You Will Master

Hands-on experience with industry-standard software.

Power BI
Power BI
MedDRA
MedDRA
Excel
Excel
Power Point
Power Point
Chatgpt
Chatgpt
Email
Email

Curriculum & Roadmap

A detailed overview of the course, including key topics, objectives, and module sequence designed to make you job-ready.

Duration
12 Weeks
💻
Mode
Online
📹
Live Sessions
72+ hrs
🔧
Projects
17+
Milestone 1 Week 1
🏢

Regulatory Affairs Fundamentals & Industry Orientation

Milestone focus: Build a strong foundation in regulatory affairs training and understand how regulatory teams function within the industry.
🎥 6 Live ⚡ 1 Project 📄 4 Docs

Understand the critical role of RA professionals and the lifecycle of pharmaceutical products within the global healthcare landscape.
Module 1
Introduction to RA & Industry Roles
Roles and responsibilities of RA professionals
RA vs Pharmacovigilance vs Clinical Research
Regulatory lifecycle of pharmaceutical products
Module 2
Global Regulatory Landscape
Overview of global regulatory systems
Compliance and inspections introduction
Milestone 2 Week 2
💊

Drug Development & Regulatory Strategy

Milestone focus: Align regulatory affairs training with drug development from discovery to post-marketing.
🎥 6 Live ⚡ 1 Project 📄 3 Docs

Learn the critical touchpoints where regulatory input shapes the development of new medicines and generic alternatives.
Module 1
Lifecycle & Touchpoints
Discovery to clinical regulatory inputs
IND, NDA, and ANDA concepts
Module 2
Submission Planning
Region-specific regulatory planning
Data requirements across phases
Milestone 3 Week 3
🌎

Global Regulatory Authorities & Frameworks

Milestone focus: Gain clarity on major global health authorities including the FDA, EMA, and CDSCO.
🎥 6 Live ⚡ 1 Project 📄 5 Docs

Master the organizational structures and approval pathways of the world's most influential health agencies.
Module 1
US System – FDA
FDA structure & BLA pathways
Review timelines and approvals
Module 2
EU & India – EMA & CDSCO
Centralized vs Decentralized procedures
Indian drug approval process
Milestone 4 Week 4
⚖️

Regulatory Guidelines & GxP Compliance

Milestone focus: Understand international guidelines (ICH) and GxP standards that form the backbone of RA.
🎥 6 Live ⚡ 1 Project 📄 4 Docs

Learn how Quality, Safety, and Efficacy standards harmonize global drug development and ensure patient safety.
Module 1
ICH Guidelines (Q, S & E)
Regulatory impact of ICH harmonization
Quality, Safety, and Efficacy series
Module 2
GxP & Compliance
GMP, GCP, and GLP overview
Regulatory inspections and audits
Milestone 5 Week 5
📂

Dossier Preparation & CTD Structure

Milestone focus: Learn how regulatory dossiers are structured and prepared using CTD and eCTD formats.
🎥 6 Live ⚡ 2 Projects 📄 6 Docs

Master the Common Technical Document (CTD) format and the transition to electronic submissions (eCTD).
Module 1
CTD Modules 1–5
Administrative, Quality, and Clinical sections
Data organization principles
Module 2
eCTD & Lifecycle
Submission lifecycle and version control
eCTD compilation basics
Milestone 6 Week 6
📤

Regulatory Submissions & Post-Approval Changes

Milestone focus: Develop hands-on understanding of submission types and managing variations post-approval.
🎥 6 Live ⚡ 2 Projects 📄 3 Docs

Understand how to maintain product compliance through updates, renewals, and change management.
Module 1
Approval Pathways
NDA and MAA applications
Generic drug submission routes
Module 2
Variations & Renewals
Change management and supplements
Impact assessment for post-approval changes
Milestone 7 Week 7
🏷️

Labeling, Artwork & Regulatory Compliance

Milestone focus: Understand labeling control, SmPC/PIL requirements, and artwork management.
🎥 6 Live ⚡ 1 Project 📄 4 Docs

Learn how critical safety information is captured in product labeling and artwork across different global regions.
Module 1
Labeling Regulations
SmPC, USPI, and PIL concepts
Safety information updates
Module 2
Artwork Management
Artwork review and change control
Cross-functional coordination
Milestone 8 Week 8
🩺

Medical Devices & Combination Products

Milestone focus: Expand your RA expertise to include device classifications and drug-device combinations.
🎥 6 Live ⚡ 1 Project 📄 3 Docs

Explore the risk-based regulatory pathways for medical devices and the unique challenges of combination products.
Module 1
Device Frameworks
Global device classification systems
Risk-based regulatory pathways
Module 2
Combination Products
Drug-device combination strategies
Special category submissions
Milestone 9 Week 9
🧠

Regulatory Intelligence & Lifecycle Strategy

Milestone focus: Develop strategic skills for senior roles by monitoring trends and updates.
🎥 6 Live ⚡ 1 Project 📄 2 Docs

Learn to track regulatory updates and assess their impact on product maintenance and strategic decision-making.
Module 1
Regulatory Intelligence
Tracking and monitoring global updates
Impact analysis of new regulations
Module 2
Lifecycle Strategy
Risk-benefit strategic assessments
Maintenance planning for mature products
Milestone 10 Week 10
🤖

RA Software & AI Tools

Milestone focus: Apply India’s first AI-enabled RA training using modern software like RIMS and DMS.

Leverage Generative AI and automated intelligence tools to streamline document reviews and compliance tracking.
Module 1
DMS & RIMS Training
Regulatory info management (RIMS)
Submission tracking software
Module 2
AI for Regulatory Affairs
AI-assisted document reviews
Automated compliance dashboards
Milestone 11 Week 11
💼

Technical & Corporate Skills

Milestone focus: Build technical skills required for daily RA operations and authority correspondence.

Prepare for the corporate environment with advanced documentation, reporting, and communication skills.
Module 1
RA Reporting Skills
Advanced Excel for tracking
Word for regulatory dossiers
Module 2
Professional Communication
Authority correspondence basics
Cross-functional coordination
Milestone 12 Week 12
🚀

Placement, Interviews & Career Launch

Milestone focus: Optimize your RA profile and master technical interviews to secure your role.

Become job-ready with ATS-friendly resumes and tailored LinkedIn profiles for Regulatory Affairs.
Module 1
Profile Optimization
ATS-friendly RA resume
Technical RA interview prep
Module 2
Mock Interviews
HR and technical mock sessions
Salary negotiation strategies
Download Curriculum
Success Stories

What Our Alumni Say

Watch their journey and read about their transformation.

Shruti Kokate

Shruti Kokate

FORTREA

Safety PV Associate

"The training covered the specific workflows used in drug safety, particularly regarding ICSR processing and MedDRA coding. Having this technical background made the onboarding process at IQVIA much easier to navigate. The course offers a realistic look at the tools and standards required for a PV Safety Associate."

Anushka Singh

Anushka Singh

CHIROK HEALTH & CORROHEALTH

Medical Coder

"I found the training on regulatory compliance and payer-specific requirements to be quite practical. It gave me a better perspective on how to minimize coding errors and reduce claim denials in a real-world setting. The structured approach to anatomy and physiology also helped me navigate complex medical records more efficiently."

Akanksha chauhan

Akanksha chauhan

CHIROK HEALTH & CORROHEALTH

Medical coder

"The program offered a realistic insight into the revenue cycle management (RCM) process, which made my transition into the industry smoother. Understanding the link between clinical documentation and reimbursement was a key takeaway for me. It prepared me well for the productivity standards and quality audits I now face daily."

Shoeb Ansari

Shoeb Ansari

ANNOVAA SOLUTIONS

Medical Coder

"I found the sessions at Pharma Daily to be informative and relevant to current market standards. The understanding I gained regarding safety databases and reporting workflows helped me feel prepared for my role at Annovaa Solutions. It is a reliable resource for gaining the necessary foundational knowledge before entering the corporate sector."

Hariom Pathak

Hariom Pathak

CORROHEALTH

Medical Coder

"I found the training on regulatory compliance and payer-specific requirements to be quite practical. It gave me a better perspective on how to minimize coding errors and reduce claim denials in a real-world setting. The structured approach to anatomy and physiology also helped me navigate complex medical records more efficiently."

Pawan Mansare

Pawan Mansare

MEDITAB

Medical Biller

"The training provided a clear understanding of the full claims submission process, from patient registration to final settlement. Learning how to analyze and correct common claim denials during the course was particularly useful for my current role. It gave me the practical knowledge needed to communicate effectively with payers and resolve billing issues."

Harsh Yadav

Harsh Yadav

TCS

Drug Safety Associate

"My experience with the program gave me a solid understanding of adverse event reporting and MedDRA coding. This foundation made it easier to adapt to the professional environment and case processing workflows at my current workplace. I appreciate the straightforward approach to teaching complex regulatory guidelines for a Drug Safety Associate role."

Avik Sarkar

Avik Sarkar

IQVIA

PV Associate at IQVIA

"The pharmacovigilance training at Pharma Daily provided a structured overview of the essential safety guidelines required in the industry. It helped clarify the core concepts, which proved useful during my interview process and transition to IQVIA. The course content is practical and aligns well with the daily responsibilities of a PV Safety Associate."

Common Queries

Regulatory Affairs Training FAQs

Everything you need to know about the program.

Founder's Message

"At ThePharmaDaily, our mission is simple — to bridge the gap between pharma education and global careers through industry-focused pharmacovigilance training. With 17,900+ pharma and clinical research jobs posted and strong HR tie-ups, we prepare candidates to master pharmacovigilance training skills such as ICSR processing, MedDRA coding, aggregate reporting, and E2B submissions, transforming them into job-ready professionals."

"Backed by 100% placement support, AI-powered career tools, and hands-on, real-world pharmacovigilance training, ThePharmaDaily has become India’s trusted launchpad for building successful careers in drug safety and pharmacovigilance. Learn. Get Certified. Get Hired. That’s ThePharmaDaily’s promise."

Mitali Jain

Founder & CEO

Founder Mitali Jain

Have any queries?

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