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International Business Jobs in Delhi, NCR and Gurgaon

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Senior Manager Regulatory affairs

Founded 2015
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via Unnati
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NCR (Delhi | Gurgaon | Noida)
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5 - 12 years
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Best in industry{{renderSalaryString({min: 1200000, max: 1800000, duration: "undefined", currency: "INR", equity: false})}}

Our client is a Delhi based healthcare platform that is dedicated to Ayurveda and provides wellness solutions to its customers that is tailored and fine-tuned to their requirements. They have created a unique balance of Ayurvedic herbs and western medicine to come up with courses and medical advice which will not only rid their patients of the illness but also helps them bring the body back into balance.Their services are available across the globe, with over 65% of their client base being from US, UK, and Canada. The company's primary focus is on Ayurveda and taking the ancient knowledge to anyone who wishes to bring back balance to their health and apply the tools in their everyday life.   As a Senior Manager Regulatory affairs, you will manage the pure and natural cosmetics range of products for new geographies and regulated markets like Canada, EU, Japan, ASEAN etc. You will file these products with regulatory authorities and reinforce the documentation as per the requirements of the current regulated markets where the products are being sold, mainly USA.   What you will do: Maintaining current knowledge of relevant regulations, including proposed and final rules Directing the preparation and submission of regulatory agency applications, reports, or correspondence Formulating or implementing regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced Providing regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. Communicating regulatory information to multiple departments and ensuring that information is interpreted correctly. Developing regulatory strategies and implementation plans for the preparation and submission of new products. Implementing or monitoring complaint processing systems to ensure effective and timely resolution of all complaint investigations. Managing activities such as audits, regulatory agency inspections, or product recalls. Reviewing materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. Evaluating regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation. Representing organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Reviewing all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Investigating product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. Overseeing documentation efforts to ensure compliance with domestic and international regulations and standards. Arranging a systematic survey of scholarly sources (such as books, journal articles, and theses) related to a specific topic or research question. Providing alerts in terms of known knowledge and safety related matter using available tools like published literature and internet sites or in collaboration with a partner. Evaluating the patentability of inventions (analysis of their main components). Identifying potential risks regarding freedom to operate (analysis of exclusive rights such as trademarks and patents owned by competitors). Preparating, drafting and filing of patent applications. Drafting of licensing contracts and elaboration of patent and trademark strategies. What you need to have: Pharma or science background with minimum 5 years of experience M.Pharma degree preferred Through knowledge of the regulatory requirements in the regulated markets with respect to herbal products. Experience of having filed and getting approved herbal products successfully in international markets. Experience of having faced the FDA audits ( preferred but not mandatory).

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