Dr. Sunil Kumar Dubey
Senior General Manager @ Emami Ltd
About
Dr. Sunil Kumar Dubey is presently working as Senior General Manager (Head) Medical Research at Emami Ltd, Kolkata. He is involved in planning and ensuring the timely execution of several preclinical and clinical studies. His expertise involves validating the effectiveness of a vast range of healthcare products and providing business development-related insights. He is responsible for developing product concept notes, technical notes, monographs, and dossiers. His team is also involved in supporting medico-marketing, product licensing activities, and training personnel from marketing and sales teams. Collectively, his efforts are towards bridging the gap between the industry, consumers, and the scientific community. He has completed various government and industry-funded projects related to new product development, alongside PK/PD investigations. All these concerted efforts have led to the grant of patents to his name as well. He has extensive research experience in the area of PK/PD modeling and simulations, the development of phytopharmaceuticals, and numerous nano-technology-based drug delivery platforms. He is proficient in regulatory affairs, adeptly navigating guidelines established by various regulatory agencies. He has over 18 years of industrial, teaching, research, and administrative experience. He was also a visiting Assistant Research Professor in the Department of Chemical and Bio-molecular Engineering at the University of Maryland, USA. He also serves as a guest faculty at various leading institutes including NIPER Guwahati, NIPER Raebareli, Jamia Hamdard, and IIT Dhanbad. He has patents and has published over 185 articles, books, and book chapters in renowned high-impact journals and presented papers at conferences in India and abroad. He is included in the list of ‘World’s Top 2% Most-Cited Scientists’ as per the Elsevier-Stanford University report. Research Area: Formulation Development and Pharmacokinetic Pharmacodynamic (PK/PD) Modelling and Simulation Photodynamic Therapy: Fabrication of a novel lipid-polymer hybrid nanoparticles for targeted drug delivery. These nanoparticles include at least one therapeutic agent or siRNA and a photosensitizer. Upon a targeted application of light in the near infrared range, these nanoparticles disrupt and release the therapeutic agent at a specific site. Pharmacokinetics/ Pharmacodynamics of Phytopharmaceuticals for Metabolic Disorders: Understanding PK/PD of active constituents present in the enriched extract is of utmost importance for getting regulatory approvals.
India
Kolkata
Research
Portfolio Management, Biopharmaceuticals, Good Manufacturing Practice (GMP), Analytical Skills, HPLC, Drug Delivery, Pharmacology, Pharmacokinetics, Drug Discovery, Analytical Chemistry, Technology Transfer, Regulatory Affairs, Chromatography, Pharmaceutics, Clinical Trials, Organic Synthesis, Pharmaceutical Research, GLP, Sop, Validation
Experience

Assistant Professor
Birla Institute of Technology & Science, Pilani
Teaching Courses- Pharmacokinetics and Clinical Pharmacy, Quality assurance & Regulatory affairs. Pharmaceutical intellectual property rights. Instrumental methods of Analysis. Pharmaceutical Management and Quality control. Compilation of various articles and case studies on regulatory in Quality assurance and regulatory affairs. Patent drafting, searching, mapping and mining. Industrial Capacity Building at Lupin Pharma and Wockhardt.

Research Scientist
Preparation and periodical review of SOPs, protocols and Clinical study reports. Method Development & Method Validation for the quantitative analysis of drugs in plasma after extraction using LCMS/MS Revision of SOPs as per current regulatory guidelines and recommendations. Bio-study of clinical subject samples as per regulatory guidelines in a GLP compliant laboratory. Error- free Documentation of the activities performed as per GLP guidelines. Calibration, Handling & Maintenance of LCMSMS (API-4000,3200,3000, Quattro premier ), Autopipettes, Handy step dispensers and equipments used in the laboratory. Application of WinNonlin PK software in Pharmacokinetic studies Application of Analyst software (1.4,1.4.1) and MassLynx. Providing technical training and support to the team members. Improving continuously the compliance to the Food and Drug Administration (FDA) Good Laboratory Practices (GLP) by Preparation and periodical review of SOPs, protocols and Clinical study reports and Revision of SOPs as per current regulatory guidelines and recommendations. Preparing response to queries raised by QA or regulatory agencies.. Providing technical training and support to the team members.
Dr. Sunil Kumar Dubey's Contact Information
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