Regulatory Affairs Associate

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    "datePosted": "2024-06-19T08:18:53.302Z",
    "description": "<h2>About Us</h2>\n<p><strong><em>Eat Well, Live Well.   At Ajinomoto Cambrooke, we build careers grounded in helping improve people’s health through nutritional therapies.  </em></strong></p>\n<p><strong><em>  </em></strong></p>\n<p><strong><em>Ajinomoto Cambrooke (ACI) was founded by parents looking to develop better solutions for their children with PKU.   Over the subsequent 25 years, we have expanded into additional therapeutic areas with a focus on enjoyable nutrition as a core part of normalizing the life for people living with medical conditions. </em></strong></p>\n<p><strong><em> </em></strong></p>\n<p><strong><em>Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way.   We seek individuals who bring an entrepreneurial mindset with a bias for action and finding solutions.   We provide an environment based in mutual respect and collaboration to support you and give you opportunities to learn and develop.</em></strong></p>\n<p><strong><em> </em></strong></p>\n<p><strong><em>Join us to find a rewarding work experience that lets you be at your best and have an impact on our patient communities.</em></strong></p>\n<p> </p>\n<p><strong><em>We do not use AI to screen applications. Applications and resumes of qualified applicants are reviewed by a real person because we value your time and believe each qualified applicant deserves thoughtful, human consideration. It’s an old‑fashioned approach—done with purpose.</em></strong></p>\n<h2>Why Join Us</h2>\n<p>Our people are the key ingredient to our success. We offer a collaborative, innovative environment where you can grow your career and make an impact on global food and health solutions.</p>\n<p> </p>\n<p>We provide a <strong>comprehensive and competitive total rewards package</strong>, including:</p>\n<p>• 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</p>\n<p>• 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</p>\n<p>• Company-Provided Mental Health and Caregiving support</p>\n<h2>Overview</h2>\n<p>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.</p>\n<h2>Qualifications</h2>\n<p>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.</p>\n<p> </p>\n<p>KNOWLEDGE, SKILLS AND ABILITIES:• 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. Experience with Microsoft SharePoint a plus.</p>\n<p> </p>\n<h2>Working Conditions / Physical Requirements</h2>\n<p>WORKING CONDITIONS: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.</p>\n<p> </p>\n<p>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 • Repetitive use of hands/arms for writing, filing, and computer work.• Ability to understand and follow GMP guidelines when in manufacturing environment area.</p>\n<p> </p>\n<h2>Responsibilities</h2>\n<p>• 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.</p>\n<h2>Salary Range</h2>$71,449.00-$87,500.00 annually plus 12.5% potential bonus\n<h2>EEO Statement</h2>\n<p>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.  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