Regulatory Assistant Manager Specialist (78884-4)
Interplace, Inc
General Position Summary This position is responsible for managing technical data and handling questions and preparing documents related to conventional food products and probiotics products by researching and coordinating with the Snr. Manager, PNF, and the third parties. This position acts as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation. This position will work closely with R&D, Quality, Sales, and Marketing to collect pertinent information and to ensure compliance for all products handled at company including special projects set forth by the Snr. Manager.
Essential Job Functions
REGULATORY SUPPORT
· Studies scientific and legal documents and parse out meaningful comparisons associated with products.
· Be the in-house advisor in scientific matters.
· Gathers, evaluates, organizes, manages, and collates information in a variety of formats.
· Ensures compliance with FDA regulations.
· Maintains familiarity with company product ranges.
· Supports R&D staff as needed at the discretion of the Snr. Manager.
· Keeps up-to-date with changes in regulatory legislation and guidelines.
· Analyzes complicated information, including trial data.
· Obtains marketing materials, reviews them, adds advice, and approves.
· Outlines requirements for labeling, storage, and packaging.
· Provides advice about regulations to manufacturers/scientists.
· Ensure that quality standards are met, and submissions meet strict deadlines.
· Prepares standardized operation procedures.
· Visits customers with the sales team and explains about products.
· Attends shows with the sales team and supports the R&D staff as needed.
· Obtains and manages third-party certification programs.
· Manages and executes label compliance and post-marketing surveillance.
· Assists the Manager in Charge with various special assignments at the discretion of the Snr. Manager.
· In addition, may have to analyze previously recorded data, respond to raised questions quickly, and be knowledgeable of all the appropriate points and basics of the subject matter in question. Be cognizant of Raw Material information, Formulas, Claims and Substantiation, and Labels and Marketing Materials.
· Assist with Regulatory research for the most current and updated food laws at the request of the Snr. Manager.
Essential Job Functions
REGULATORY SUPPORT
· Studies scientific and legal documents and parse out meaningful comparisons associated with products.
· Be the in-house advisor in scientific matters.
· Gathers, evaluates, organizes, manages, and collates information in a variety of formats.
· Ensures compliance with FDA regulations.
· Maintains familiarity with company product ranges.
· Supports R&D staff as needed at the discretion of the Snr. Manager.
· Keeps up-to-date with changes in regulatory legislation and guidelines.
· Analyzes complicated information, including trial data.
· Obtains marketing materials, reviews them, adds advice, and approves.
· Outlines requirements for labeling, storage, and packaging.
· Provides advice about regulations to manufacturers/scientists.
· Ensure that quality standards are met, and submissions meet strict deadlines.
· Prepares standardized operation procedures.
· Visits customers with the sales team and explains about products.
· Attends shows with the sales team and supports the R&D staff as needed.
· Obtains and manages third-party certification programs.
· Manages and executes label compliance and post-marketing surveillance.
· Assists the Manager in Charge with various special assignments at the discretion of the Snr. Manager.
· In addition, may have to analyze previously recorded data, respond to raised questions quickly, and be knowledgeable of all the appropriate points and basics of the subject matter in question. Be cognizant of Raw Material information, Formulas, Claims and Substantiation, and Labels and Marketing Materials.
· Assist with Regulatory research for the most current and updated food laws at the request of the Snr. Manager.
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