New Posting:
Regulatory Affairs Specialist
A Regulatory Affairs Specialist wanted by Prosweetz Ingredients Incorporated in Edison, New Jersey. MS in Bioengineering. At least 1 year of experience in the healthcare industry with knowledge of FDA and intellectual property
Job duties:
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Identify and evaluate new bio-engineered ingredients and blends; Coordinate with external parties, including clinical study associations, to perform due diligence and studies to evaluate feasibility of innovative processed ingredients, genetic-modified ingredients, to ensure that regulatory compliance has/will be met.
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Acquire and review required scientific and technical documentation for all types of regulatory submissions; Ensure that all regulatory submittals are comprehensive, timely and accurate, and are compliant with applicable standards. Maintain records regularly.
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Identify data needed; obtain these data and ensure that they are effectively presented for the registration of products.
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Critically evaluates the regulatory acceptability of proposed food, dietary supplement and health food claims, rationales and substantiation, and suggests allowable alternative claims and/or improved evidence as necessary.
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Review ingredient and product information including, but not limited to ingredient specifications, premix ingredient formulas, labels, SDS, marketing/sales literature, labeling and advertising materials for regulatory compliance; analyze and recommend appropriate changes internally, and externally for the companies suppliers and clients.
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Determine whether ingredients for foods, dietary supplements and medical foods are GRAS/non GRAS; Monitors GRAS self-affirmation process and tracks in regulatory database
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Provide regulatory input to product life-cycle planning.
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Maintain annual licenses; registrations and patent information.
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Monitor regulatory applications and impact of changing regulations on submission; Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies.
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Ensure product safety issues and product-associated events are reported to regulatory agencies
Please send resume to Prosweetz Ingredients Incorporated, 98A Mayfield Avenue, Edison, NJ 08837