Subas Chandra Mohapatra B.Sc, M.Sc, MBA

Subas Chandra Mohapatra is an accomplished executive with a rich history of delivering exceptional business results. With extensive experience spanning 25 years, he possesses a deep knowledge of Quality Management System, Regulatory Affairs and regulatory processes, emphasizing efficiency, productivity, and organizational
consistency. His passion for coaching, mentoring, counseling, and people development has been instrumental in fostering a culture of excellence. Moreover, Subas has made significant contributions by integrating quality management systems with regulatory compliance to enhance business deliverables. In his current role as a Regulatory CMC Project Lead at Novartis Healthcare in India, Subas has spent a decade managing multiple global regulatory projects. These encompass life cycle management, registration, regulatory process review and simplification, data analysis, coaching, and mentoring in the field of Regulatory Affairs CMC. Subas's diverse work experiences include serving as a Senior Group Leader in Regulatory Affairs at Ranbaxy Labs in Delhi, India. In this role, he led teams across manufacturing locations and corporate R&D, focusing on compliance, drug product registration, life cycle management, training and development, site GXP inspections, process review and simplifications, and supporting quality, manufacturing, and business rationalization activities. He has also worked as a Deputy Manager at Dr. Reddy's Laboratories, Generics Division in Hyderabad, India. There, he played a pivotal role in establishing the Audit and Compliance function, preparing and submitting ANDAs, auditing technical functions, strategic sites, vendors, and CROs to ensure compliance in the context of ANDAs. He was responsible for writing SOPs, and Quality Manuals, imparting training, and coaching to associates. Subas holds a Master's degree in Organic Chemistry from Sambalpur University and a Bachelor's degree in Applied Science (Chemistry) from Bhadrak (Auto.) College. He also earned an Executive MBA in Pharmaceutical Marketing and Management from The ICFAI University, Tripura. He has earned a number of credits, awards and rewards by going beyond for his exceptional contributions to the business growth. His top skills encompass Quality management System, Audit and Compliance, Regulatory CMC cum Submissions, Pharmaceutical management, and Team Building. Subas Chandra Mohapatra stands as a seasoned professional with a wealth of experience and expertise in Regulatory Affairs, Compliance, and Quality Management, contributing significantly to the pharmaceutical industry's excellence. In addition to his professional achievements, Subas has a history of active engagement in social services, including plantation, teaching, career mentoring, Yoga and Meditation techniques and personal financial planning. He's been an integral part of Novartis' CSR activities and is recognized as a top 10 contributor. Fluent in English, he
possesses exceptional skills in Quality Management System, quality control, and QA. Subas's extensive career history reflects his expertise in handling stakeholders at all levels, understanding consumer needs, change management, process simplification, project management, and validation, among other valuable proficiencies. His ability to deal with regulatory authorities and GXP inspections, coupled with training programs and SOP management, has made him a trusted leader in the industry. Subas Chandra Mohapatra is a self-motivated professional dedicated to driving quality and compliance in the pharmaceutical sector while actively contributing to social and community development.
He strongly believes, happiness and satisfaction in life has only four dimensions, Health, Career, Finance and Relationship. He is authoring a book on “4 pillars of life”.

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