Regulatory Affairs Manager

The Regulatory Affairs Manager serves as the regulatory subject matter expert for medical nutrition and functional foods for Ajinomoto Cambrooke, Inc. This position is responsible for supporting the development of new and updating existing formulations regarding ingredient and claims compatibility with regulatory and Ajinomoto quality guidance. The position will manage all necessary documentation necessary to support quality assessment for new product launch, including labeling & packaging requirements. Where applicable the position will seek assistance from external consultant(s) to ensure compliance with local/government rule(s) for any new or revision requirements for the medical nutrition business.

Examples of Work Performed

• Provide regulatory guidance for labeling, formula compliance and marketing of medical nutrition and functional foods in North America and International markets.
• Review raw material and ingredient compositions for regulatory conformity based on industry guidelines in the US and their compatibility with FSMP regulations and other international restrictions.
• Participate in the design of new product launches or revision of an existing product by providing regulatory expertise on product formulation, package design, labeling, and to substantiate claims, or suggest alternatives to ensure regulatory compliance.
• Develop the nutrition fact panel, ingredient statements and other necessary claims for medical nutrition formulae and functional foods from formulations.
• Work with Marketing and Graphics team to transition the finished product nutrition facts and other relevant information on to product packaging / specification sheets etc.
• Assist QA in completing the quality assessment and assuring that all regulatory requirements are achieved for the finished product information sheets and labels.
• Develop methods for assigning and tracking labeling process, including a system to provide access to approved and current label documents to Operations team.
• Update and maintain the standard operating procedures for nutrition databases, ingredient documentation, labeling and regulatory roles.
• Assist and guide Regulatory Support Specialist with product documentation with respect to registration of formula and /or functional foods to comply with international regulations.
• Monitor global regulatory developments through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues to management.
• Other duties as assigned.

Education and/or Experience

• Bachelor of Science degree in Nutrition, Food Science, Biology, or related discipline
• 5 years or more experience in Food Industry in regulatory role required
• Minimum 3 years hands-on experience working directly on labeling
• Active affiliations: Food and or dietary supplement manufacturing association affiliations are a plus

Minimum Qualification Requirements

• Proficient in US food regulations. Ability to self-teach the nuances of medical nutrition and Orphan Drug Act.
• Understanding of International Regulations (Canada, EU, LATAM, ASPAC) related to medical nutrition preferred.
• Ability to solve or seek out answers to provide guidance on regulatory matters.
• Highly organized, able to prioritize, work in a fast-paced environment and have attention to detail.
• Familiar with nutritional databases.
• Proficient in Microsoft Office programs.
• Able to work cross functionally across business units in shepherding the new product regulatory and label review process.
• Demonstrated organization skills, attention to details and strong communication skills.
• Ability to work under tight deadlines and changing priorities.

Working Conditions

• Majority of work is completed in an office setting working inside a controlled temperature 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 and glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines.

Ajinomoto Cambrooke, Inc. is an Affirmative Action, Equal Opportunity Employer-Vets/Disabled, committed to a diverse workforce. If you need assistance with completion of an application for employment, please contact Human Resources Department at 978-862-1980.