Regulatory Affairs Associate

Regulatory Affairs Associate

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.

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.• 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.

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.

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.

Responsibilities include performing routine research and administrative functions to ensure company products are following US and Canadian medical food regulations and third-party certification requirements. The role involves contributing to completion of routine technical tasks such as proof-reading product packaging and nutritional information. It also includes working closely with product development and graphics teams to ensure technical accuracy and compliance of packaging and labelling artwork. The position requires assisting with maintaining nutrition information for U.S. and international products, confirming appropriate calculation methods by country, verifying rounding rules, acceptable use regulations for ingredients, standards of identity. The Regulatory Affairs Associate will identify risks or discrepancies that may impact product release, shipment or compliance and escalate promptly to appropriate stakeholders. They will assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions. They will monitor and reconcile version control issues for labels, packaging and regulatory documents; coordinates corrections to prevent release delays or compliance gaps. They will review product claims and substantiation documents for compliance in the US and Canada. The role also includes assisting RAM with cross functional labelling review process. They will assist RAM and QA team in maintaining and acquiring product certifications necessary to support the business. They will monitor US FDA and Health Canada food and medical nutrition regulations through newsletters, government websites, and other methods. They will assist with raw material reviews for regulatory conformity based on industry guidance in the US their compatibility with FSMP regulations and other international restrictions. They will collaborate with International RA team as necessary to provide documentation needed for international product registrations. They will adhering to all company SOPs with regards quality and safety. Other duties as assigned.

Salary Range: $71,449.00-$87,500.00 annually plus 12.5% potential bonus

EEO Statement: 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.