Regulatory Affairs Associate

About the role

The Regulatory Affairs Associate plays a crucial role in the regulatory affairs team at Ajinomoto Cambrooke, Inc. They assist the Regulatory Affairs Manager (RAM) with research, review, and approval of product packaging and labelling materials.

Responsibilities

• Assist in ensuring product formulations and claims comply with US FDA, Health Canada, and EU, South America, and Australia Food for Special Medical Purpose (FSMP) regulations as well as Ajinomoto quality guidance.
• Contribute to completing 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 RAM to investigate and resolve discrepancies related to packaging, labeling, or documentation, and collaborate with internal teams to implement rapid, compliant solutions.
• Monitor and reconcile version control issues for labels, packaging, and regulatory documents; coordinate corrections to prevent release delays or compliance gaps.
• Review product claims and substantiation documents for compliance in the US and Canada.
• Aid in cross-functional labelling review processes.
• Maintain and acquire 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.
• Support the RAM in raw material reviews for regulatory conformity based on industry guidance in the US and other international restrictions.
• Collaborate with the International RA team as necessary to provide documentation needed for international product registrations.

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.

Qualifications

• Strong written and verbal communication skills.
• Strong analytical skills to troubleshoot 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.
• Able to work under tight deadlines and changing priorities.
• Able to follow Standard Operating Procedures (SOPs) and 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.

Skills

• Strong written and verbal communication skills.
• Strong analytical skills to troubleshoot 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.
• Able to work under tight deadlines and changing priorities.
• Able to follow Standard Operating Procedures (SOPs) and 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.

Benefits

• Comprehensive and competitive total rewards package, including competitive pay and annual bonus opportunity.
• 401(k) with Company Contributions.
• Medical, Dental, and Vision coverage.
• 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.

Pay

$71,449.00 - $87,500.00 annually plus 12.5% potential bonus.

Schedule

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

Physical Requirements

• Ability to visually inspect documents, labels, and other materials.
• 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 25 pounds occasionally.
• Ability to understand and follow GMP guidelines when in manufacturing environment area.