Regulatory Affairs Associate

Ajinomoto Health & Nutrition North America•Ayer, MA

7d•Onsite

About The Position

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, South America and Australia Food for special medical purpose (FSMP) regulations as well as Ajinomoto quality guidance.

Requirements

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.
Strong written and verbal communication skills.
Strong analytical skills to trouble shoot regulatory discrepancies or queries in real time to support uninterrupted product flow
Able to exercise sound judgment in evaluating issues, determining appropriate actions, and knowing when and to whom matters should be escalated.
Able to maintain strict confidentiality of sensitive regulatory, quality and product related information in accordance with department and company policies.
Demonstrates a high level of integrity and commitment to compliance.
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.

Nice To Haves

Experience with Microsoft SharePoint a plus.

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.
Works 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.
Identify risks or discrepancies that may impact product release, shipment or compliance and escalate promptly to appropriate stakeholders.
Assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions
Monitor and reconcile version control issues for labels, packaging and regulatory documents; coordinates corrections to prevent release delays or compliance gaps
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.