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Regulatory Affairs Associate

$71.45k - $87.5k

JobsInMass.com

About the Role 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 with research, review, and approval of product packaging and labelling materials, ensuring product formulations and claims comply with US FDA, Health Canada, and EU, South America, and Australia regulations as well as company quality guidance. Responsibilities Perform routine research and administrative functions to ensure company products follow US and Canadian medical food regulations and third‑party certification requirements. Complete 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. Collaborate with the Regulatory Affairs Manager to make decisions on claims, callouts, and third‑party certifications. Maintain nutrition information for U.S. and international products, confirm appropriate calculation methods, verify rounding rules, acceptable use regulations for ingredients, and standards of identity. Identify potential risks or discrepancies that may impact product release, shipment, or compliance and promptly elevate to appropriate stakeholders. Investigate and resolve discrepancies related to packaging, labeling, or documentation, collaborating with internal teams to implement rapid, compliant solutions. Coordinate corrections to prevent release delays or compliance gaps and monitor version control issues for labels, packaging, and regulatory documents. Review product claims and substantiation documents for compliance in the US and Canada. Assist in the cross‑functional labeling review process and help acquire necessary product certifications. 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 and compatibility with FSMP regulations. Collaborate with the International Regulatory Affairs team to provide documentation required for international product registrations. Adhere to all company SOPs related to quality and safety. Physical Requirements Visually inspect documents, labels, and other materials. Sit for a minimum of six hours per day. Stand, walk, bend, and reach above head on a regular basis. Lift or carry up to 25 pounds occasionally. Perform repetitive use of hands/arms for writing, filing, and computer work. Understand and follow GMP guidelines when in a manufacturing environment. Education, Certifications And Experience Bachelor of Science degree in Nutrition, Food Science, Biology, Chemistry, or a related discipline. 0–2 years of professional experience; preferably in the food, beverage, or dietary supplement industry. Working knowledge of food and nutrition regulations for the US, Canada, and EU preferred. Knowledge, Skills and Abilities Strong written and verbal communication skills. Strong analytical skills to troubleshoot regulatory discrepancies or queries in real time to support uninterrupted product flow. Sound judgment in evaluating issues, determining appropriate actions, and knowing when and to whom matters should be escalated. Maintain strict confidentiality of sensitive regulatory, quality, and product‑related information in accordance with department and company policies. Demonstrate a high level of integrity and commitment to compliance. Self‑motivated with the ability to drive projects with minimal guidance. Ability to manage multiple projects and tasks. Ability to work under tight deadlines and changing priorities. Follow SOPs and provide improvement recommendations for existing SOPs. Detail‑oriented with strong analytical, problem‑solving, and organizational skills. Proficient in Microsoft Office suite. Experience with Microsoft SharePoint a plus. Benefits Competitive Pay and Annual Bonus Opportunity 401(k) with Company Contributions Medical, Dental, and Vision – Effective Day 1 Paid Time Off, Company Holidays, and Floating Holidays Paid Parental Leave Wellness Programs and Yearly Wellness Reimbursement Work Flexibility Company‑Paid Life and Disability Insurance Employee Assistance Program (EAP) Tuition Reimbursement Opportunities Career Growth and Development within a Global Organization Company‑Provided Mental Health and Caregiving support Salary: $71,449.00–$87,500.00 annually plus up to 12.5% potential bonus. Ajinomoto Cambrooke, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, age, physical or mental disability, national origin, veteran status, or any other basis protected by state, federal, or local law. All employment is decided on the basis of qualifications, merit, and business need. #J-18808-Ljbffr

Vacancy posted 4 days ago
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