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Regulatory Support Specialist

Company: Ajinomoto Health and Nutrition
Location: Ayer
Posted on: January 5, 2022

Job Description:

* Support compilation and maintenance of regulatory documentation for FSMP/Medical Foods for existing and new products. * Coordinate efforts associated with the preparation of regulatory documents and/or submissions/registrations considering communicated priorities by MA Director. * Prepare additional information as requested by regulatory agencies. * Liaise with ACI PD Team regarding the collection/preparation of laboratory samples in response to regulatory agencies requests and approved by MA Director. * For new countries, assist International MA Director to organize country specific requirements in preparation for future product submissions. * Establish and coordinate shelf-life validation studies for formula products to meet the needs for documentation of nutrients at end of code for certain international requests. * Work with Food team in compiling necessary regulatory documents for existing and new food products being exported to international markets. * Co-ordinate certificate of analysis, manufacturer's declaration and other regulatory documents from QA test results, necessary to support each country specific international shipment. * Utilize tools such as ACCESS and Genesis Nutrition Analysis Software to access information required for registration documents/submissions. * Organize, file, and communicate information/research/documents in accordance with MA Directors & ACI PD Team direction. * Adhering to all company SOPs with regards quality and safety. * Other duties as assigned.

Keywords: Ajinomoto Health and Nutrition, Nashua , Regulatory Support Specialist, Other , Ayer, New Hampshire

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