Sakaar Rajput Email & Phone Number

As a dedicated professional with extensive experience in the pharmaceutical industry, I bring a strong background in Research & Development (R&D) validation, regulatory affairs, and eCTD submissions across global markets. My expertise spans the complete lifecycle of pharmaceutical products, from drug substance validation to regulatory compliance in Europe, Australia, and Canada.Starting my career in the R&D validation department, I worked on validating drug substances for various dosage forms. I gained in-depth knowledge of the processes required to ensure drug safety, efficacy, and quality. My experience includes reviewing and analyzing critical validation data to support the successful development and commercialization of pharmaceutical products.In recent years, I have focused on regulatory affairs, specializing in preparing and submitting eCTD dossiers in compliance with ICH and EMA guidelines. I have managed submissions and post-approval variations for the European, Canadian, and Australian markets, ensuring all regulatory requirements are met. My expertise includes handling complex variation changes, aligning with global regulatory frameworks, and navigating post-approval processes seamlessly.With a commitment to quality and compliance, I thrive in fast-paced, regulatory-driven environments. My goal is to contribute to the success of pharmaceutical projects by ensuring that all regulatory and validation standards are rigorously adhered to, fostering a pathway for successful product launches and post-market surveillance.