Certificate Course in Regulatory Affairs – US

(Drug Product)

About the Course

This is an intensive weekend course into the world of regulatory affairs, with a focus on the US market – Drug Product. It will equip participants with the tools and knowledge needed for a career as a regulatory professional. The live, instructor-led course will feature detailed case studies, hands-on learning, and weekly assignments to help you master relevant in-demand skills. The course is ideal for students aspiring to choose RA as a career path, pharmaceutical professionals looking to transition into regulatory affairs, and those looking to refresh their knowledge and stay up to date about this highly dynamic field.

Course Instructor

Daliya Bharati is an Intellectual Property and Regulatory Affairs expert with 18 years of experience managing diverse patent and regulatory matters, from product inception and design to registration and launch. She has led numerous patent and product filings and contributed to product portfolio planning as well as product lifecycle management. Daliya has extensively worked on regulatory strategy design and execution, including meetings with FDA, pre-IND filings, ANDA submissions, and post-approval change assessments.

Course Contents

The course has 6 modules

Module 1: Introduction to Regulatory Affairs

Module 2: US Regulatory Architecture

Module 3: Product Development and ICH

Module 4: Pharmaceutical Quality and cGMP

Module 5: Dossier Compilation, Electronic Submissions and Dossier Review

Module 6: Product Lifecycle Management

Seats

20

Certification Criteria

Certification is achieved by submission of all required assignments, class participation and online evaluation.

Duration

Dates: To be announced

8 week course, 16 days (Saturday & Sunday)

40 hours, 2.5 hours per session

Fee Structure

INR 30,000

Add-On: 1-month Internship with Regulatory Affairs at Rubicon Research to gain practical exposure – INR 10,000/-

Admission Procedure

Email info@rubiconacademy.in expressing your interest in this course with the following details:

Name:

Highest Qualification:

Experience:

Contact Number:

Contact us for further details at: +91 22 6141 4000 Ext. 137

* Rights to admission reserved with Rubicon Academy