Job Description

The Regulatory Affairs Associate is a key contributor to the regulatory affairs team at Ajinomoto Cambrooke, Inc. This position is responsible for assisting the Regulatory Affairs Manager (RAM) with research, review and approval of product packaging and labelling materials.  The Regulatory Affairs Associate will work on ensuring product formulations and claims are compliant with US FDA, Health Canada, and EU Food for special medical purpose (FSMP) regulations as well as Ajinomoto quality guidance.

QUALIFICATIONS (EDUCATION, CERTIFICATIONS AND EXPERIENCE):
Bachelor of Science degree in Nutrition, Food Science, Biology, Chemistry, or related discipline
0-2 years professional experience; preferably in food, beverage, or dietary supplement industry.
Working knowledge of food and nutrition regulations for US, Canada and EU preferred.

KNOWLEDGE, SKILLS, AND ABILITIES:
Strong written and verbal communication skills.
Self-motivated with ability to drive projects with minimal guidance.
Able to manage multiple projects and tasks.
Ability to work under tight deadlines and changing priorities.
Ability to follow SOPs and the know how to provide improvement recommendations of existing SOPs.
Detail oriented with strong analytical, problem-solving, and organizational skills.
Proficient in Microsoft Office suite. Experience with Microsoft SharePoint a plus.
Working Conditions / Physical Requirements

WORKING CONDITIONS:
Majority of work is completed in an office setting working inside a controlled office environment. The noise level in the work environment is generally low.
The employee will on occasions be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines.

PHYSICAL REQUIREMENTS:
Position requires the ability to sit for a minimum of 6 hours per day.
Ability to stand, walk, bend over, and reach above head on a regular basis.
Ability to lift or carry up to 20 pounds occasionally and repetitive use of hands/arms for writing, filing, and computer work.
Ability to understand and follow GMP guidelines when in manufacturing environment area.
Responsibilities
Performs routine research and administrative functions to ensure company products are following US and Canadian medical food regulations and third-party certification requirements.
Contribute to completion of routine technical tasks such as proof-reading product packaging and nutritional information.
Work closely with product development and graphics teams to ensure technical accuracy and compliance of packaging and labelling artwork.
Works closely with RAM to make decisions pertaining to claims, callouts, and third-party certifications.
Assists with maintaining nutrition information for U.S. and international products, confirm appropriate calculation methods by country, verifying rounding rules, acceptable use regulations for ingredients, standards of identity.
Review product claims and substantiation documents for compliance in the US and Canada
Assist RAM with cross functional labelling review process.
Assist RAM and QA team in maintaining and acquiring product certifications necessary to support the business.
Monitor US FDA and Health Canada food and medical nutrition regulations through newsletters, government websites, and other methods
Assist with raw material reviews for regulatory conformity based on industry guidance in the US their compatibility with FSMP regulations and other international restrictions.
Collaborate with International RA team as necessary to provide documentation needed for international product registrations.
Adhering to all company SOPs with regards quality and safety.
Other duties as assigned.