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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:



  1. 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.

  2. 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.

  3. Identify data needed; obtain these data and ensure that they are effectively presented for the registration of products.

  4. 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. 

  5. 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.

  6. Determine whether ingredients for foods, dietary supplements and medical foods are GRAS/non GRAS; Monitors GRAS self-affirmation process and tracks in regulatory database

  7. Provide regulatory input to product life-cycle planning.

  8. Maintain annual licenses; registrations and patent information.

  9. Monitor regulatory applications and impact of changing regulations on submission; Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies.

  10. 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

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