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Sudeep Nutrition Pvt. Ltd. forms a part of the Sudeep Group of industries which also includes Sudeep Pharma Pvt. Ltd., Sudeep Pharma USA as well as a joint venture with leading German manufacturer of excipients and coatings JRS Pharma. Committed to excellence, innovation, and quality, Sudeep Nutrition specializes in providing cutting-edge ingredients for the Food, Beverages, and Dietary Supplement sectors. With a strong foundation in pioneering technologies like Spray Drying, Encapsulation, Blending, Granulation, and Trituration, the company stands as a beacon of progress and ingenuity in the field of nutritional solutions.
Post : Executive - Regulatory Affairs
Job Responsibilities
• Issuance of Prior Notice to USFDA For sample.
• Preparation of Statement / declaration (E.g. - Allergen, Non GMO, Food Grade, WADA, Nitrosamine Risk Assessment, Heavy Metal Impurities, Elemental Impurities, Gluten Free Statement etc.) of customer scope products as per their country requirements.
• Customer Questionnaire filling and submission with supporting documentation set.
• Basic knowledge of Company and Product registration into international countries like Europe, Indonesia, Brazil, GCC countries etc.
• Able to respond to customer queries.
• Basic knowledge of FSSAI/FDA registration and their guidelines.
• Ensure that a company's products comply with the regulations of the regions where we want to distribute them.
• Keep up to date with national and international legislation, guidelines and customer practices.
• Prepare submissions of additional product, changes in establishment etc. for state and central regulatory authorities.
• Work closely with R&D, Quality Assurance, and Marketing teams to provide regulatory guidance during product development, ensuring compliance from the initial concept to market release.
• Monitor changes in regulations and industry trends, providing insights and recommendations to ensure the company's regulatory strategies align with market demands.
• Basic knowledge of Food Certification like BRCGS, FSSC 22000, ISO 22000, HACCP, Kosher, HALAL, EIA etc.
• Preparation of Qualitative and Manufacturing Process Equivalence reports.
• Basic Knowledge of Government tender documents preparation.
• Preparation of documents regarding custom clearance.
Candidate Profile
Qualification : B.SC., M.Sc., B.Pharm, M.Pharm, B.Tech, M.Tech any
Experience : Graduate with 2 Years of Experience
Location : Poicha (Rania), Vadodara
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