Regulatory Assistant Manager (1050)

Torrance, CA, USA

Job Type

Full-time; Direct-hire

About the Role

  • 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

  • Acts as representative of Morinaga Nutritional Foods, Inc., in professional associations

  • Maintains familiarity with company product ranges

  • Supports R&D staff as needed at the discretion of the Senior 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 Senior 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 Senior Manager

  • Answers any question relating to technical data information

  • Prepares customized data for each customer

  • Updates, revises the information data to comply with each country’s regulations and requirements

  • Conducts research to meet customers’ requests as needed

  • Updates and revises the company data as needed

  • Files and maintains the information data per good document control; will provide document control tactics to help assist document archives

  • Claim investigation and processing

  • Archiving quality-related documents, internal quality packets from the customer

  • Developing quality documentation and drafting quality control documentations

  • Reviewing, completing, sign-offs, and approving quality assurance for customers

  • Strictly adhering to federal, state, and regional compliance for food safety

  • Ensuring food safety protocols are being conducted on and off-site (including trade shows)

Requirements

  • Bachelor’s Degree BS or BA; preferably in Science

  • Past experience in quality, regulatory, technical or nutritional-scientific roles

  • Past experience in a supervisory and/or management role

  • Research skills and project management experience

  • Excellent verbal and written communications skills

  • Strong PC and MS Office skills

  • Excellent analytical and problem-solving skills

  • Ability to multi-task, prioritize, and manage time effectively

  • PCQI certification preferred

  • SQF/HACCP training preferred