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A pharmaceutical industry professional who has worked in senior-level positions for corporate |
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organizations and as a consultant based in North America and India in close association with |
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clients in India, North America, China etc., representing their interests in worldwide markets, and |
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regulatory agencies in North America, Europe, and other countries. |
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Over 23 years of experience in North American and European regulatory affairs, cGXP, |
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compliance management, conceptualization, design and set-up of state-of-the-art |
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manufacturing and testing facilities for pharmaceuticals, biopharmaceuticals, APIs, excipients, |
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medical devices, and allied products, business development, and international trade in the |
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pharmaceutical and related industries. |
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Knowledge of current industry regulations, as well as future policy shifts in several countries, |
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insight into how regulatory agencies think, and what data they will need to approve specific |
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products. |
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Personal contacts in international markets, and extensive experience in interacting with regulatory |
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agencies in the USA, Canada, the European Union and other countries. |
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Strong project management and interpersonal skills. |
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Over 47 years of industrial experience at senior-level positions in pharmaceutical project |
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implementation, manufacturing, quality assurance, and regulatory affairs in several |
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organizations (Hindustan Antibiotics Ltd., Goa Antibiotics Ltd., Torrent Pharmaceuticals Ltd.), and |
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as a consultant to the Indian pharmaceutical industry. |
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Extensive experience and strong skills in regulatory documentation, SOPs, validation procedures, |
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quality assurance and manufacturing controls. |
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Expert in implementation of quality systems and international GMP norms as required by WHO and |
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ISO-9002 |
