In a landmark move that bridges the gap between science, regulation, and innovation, the National Institute of Pharmaceutical Education and Research (NIPER) Mohali has announced the launch of the Executive Post-Graduate Diploma Course in Regulatory Sciences, specializing in Chemistry, Manufacturing, and Controls (CMC).
The one-year industry-aligned program will commence in January 2026, offering a transformative learning experience designed to build the next generation of regulatory science professionals capable of navigating complex global compliance landscapes.
What Is Regulatory Science and Why It Matters
Regulatory Science is the backbone of global drug development. It integrates scientific principles with regulatory frameworks to ensure that medicines, biologics, and medical devices are safe, effective, and high-quality.
In an era where pharmaceutical innovation is advancing rapidly, professionals who understand CMC documentation, Quality by Design (QbD), Quality Risk Management (QRM), and global submission strategies are in high demand.
This new NIPER Mohali program aims to fill that skill gap — blending technical depth with regulatory insight to create professionals ready for both Indian and global regulatory careers.
Course Overview
The Executive Post-Graduate Diploma in Regulatory Sciences (Specialization: CMC) is a one-year in-person program, specifically crafted for:
Mid-career professionals in pharma, biotech, and regulatory affairs
Scientists involved in formulation, QA/QC, and CMC documentation
Graduates aspiring to join regulatory or quality functions
Course Objective
To equip learners with comprehensive knowledge of global regulatory frameworks, CMC dossier development, and the scientific principles of product quality that drive approval and lifecycle management.
Core Focus Areas
The program offers in-depth coverage of key regulatory and scientific domains:
Global Regulatory Frameworks
ICH, USFDA, EMA, PMDA, and WHO guidelines
Common Technical Document (CTD) structure and eCTD implementation
Country-specific submission pathways
Chemistry, Manufacturing, and Controls (CMC)
Regulatory expectations for API and finished product manufacturing
Analytical method validation and specification setting
Control strategies and lifecycle management
Quality by Design (QbD) & Quality Risk Management (QRM)
Application of QbD principles to formulation development
ICH Q8, Q9, and Q10 integration
Risk-based decision making in product development
Dossier Preparation & Global Submissions
Hands-on training on Module 2 & 3 of CTD
Real-world case studies on USFDA and EMA submissions
Gap assessment and deficiency response management
Regulatory Intelligence & Lifecycle Management
Post-approval changes (PACs) and global harmonization
Pharmacovigilance and labeling updates
Digital transformation in regulatory operations
Key Features
✔ Hands-on exposure to real dossier preparation and submission mock exercises
✔ Interactive case studies covering global regulatory challenges
✔ Guidance from top regulatory professionals across Indian and international pharma
✔ Practical learning aligned with industry expectations
✔ Career-oriented approach bridging academia and global compliance
Esteemed Advisory Panel
The program is guided by an eminent Advisory Panel of thought leaders and regulators, ensuring global relevance and credibility:
Mr. Srinivas Lanka – Chairperson, APDC, NIPER Mohali
Dr. Rajeev Singh Raghuvanshi – Drug Controller General of India (DCGI)
Dr. Rashmi Kulshreshtha – Founder & CEO, Regulatory Wisdom
These advisors bring decades of expertise in policy, industry practice, and academic leadership to shape a truly world-class program.
Guidance from Leading Experts
The course content and delivery are further strengthened by contributions from distinguished regulatory and industry experts:
Ms. Rajni Jha, Consultant & Independent Director, IOL Chemicals & Pharmaceuticals
Mr. Adi Karunakar, EVP & Global Head – Regulatory Affairs, Dr. Reddy’s Laboratories
Dr. Prafulla Kumar Nandi, Strategic Advisor & Co-Founder, PharmAdvis Solutions LLP
Dr. Varsha Pradhan, Partner – Regulatory Affairs, Roche India
Dr. Binnu Singh, Regulatory Project Head, Abbott Healthcare
Mr. Sumit Tripathi, DGM – Regulatory Affairs, Aculife Healthcare Pvt. Ltd.
Their mentorship ensures that learners receive practical, current, and global insights — not just textbook theory.
Course Details
Program Name: Executive Post-Graduate Diploma in Regulatory Sciences (Specialization: CMC)
Duration: One Year (In-Person Classes)
Commencement: January 2026
Mode: On-campus (NIPER Mohali)
Email for Enquiry: pgdra@niper.ac.in
Website: www.niper.gov.in
Apply Now: https://lnkd.in/gTwX5eCM
Career Opportunities
After completing this program, professionals can explore advanced roles such as:
Regulatory Affairs Executive / Manager (CMC)
Dossier Specialist – Global Submissions
Quality Systems / QbD Specialist
Lifecycle Management Lead
CMC Writer or Technical Regulatory Associate
Given the global shortage of skilled regulatory professionals, graduates will be well-positioned to contribute to pharma, biotech, and consulting organizations.
Why This Program Matters
As pharmaceutical development becomes increasingly complex and globalized, CMC regulatory expertise has emerged as a critical differentiator.
This program is not just another diploma — it’s a strategic learning pathway designed to produce professionals who can interpret, apply, and influence regulatory frameworks across jurisdictions.
By aligning with international regulatory expectations and industry needs, NIPER Mohali’s initiative stands as a first-of-its-kind regulatory education model in India, setting a benchmark for the future.
Final Thoughts
The Executive Post-Graduate Diploma in Regulatory Sciences (CMC) represents a major step forward for India’s pharmaceutical education ecosystem.
It combines academic rigor, industry relevance, and global vision — preparing professionals who can contribute to regulatory excellence worldwide.
If you are passionate about bridging science with compliance and aspire to shape the future of global pharma, this program offers the perfect launchpad.
👉 Apply today and be part of India’s new wave of regulatory innovators.
📩 Apply Now | 🌐 Visit Official Website