Regulatory Manager

ABOUT KATE FARMS:

Kate Farms is a company with heart. Our company was founded on the belief that good nutrition leads to good health, and good health opens the door to endless possibilities. That’s why our mission is to make nutrition the cornerstone of healthcare, so people can live their best lives. We are a medical food company that makes complete nutrition formulas for people who have a medical need for liquid nutrition.

Kate Farms works to be the place where a diverse mix of talented individuals want to come, to stay and do their best work. Ensuring a diverse and inclusive workplace where we learn from each other is core to Kate Farms’ values. We are an equal opportunity employer and fully focused on equality; we believe deeply in diversity of race, gender, sexual orientation, religion, ethnicity, national origin and all the other fascinating characteristics that make us different. We invite you to come do the best work of your life with us at Kate Farms.

• This position could be located in Santa Barbara, CA OR anywhere remote in the United States.

POSITION OVERVIEW:

The new “Regulatory Manager” for Kate Farms will be an integral part of the QA & Regulatory Affairs team for ensuring a full slate of safe, wholesome, and clinically effective food products in their development and finished phase meet regulatory and quality standards.

The Regulatory Manager will be the in-house expert for all regulatory affairs within our rapidly growing company. The scope of the role includes providing regulatory support throughout the product development & commercialization process, as well as keeping the company abreast of new regulations and their implications to the business. The role will be responsible for translating regulatory requirements into business solutions as well as proactively ensuring that the company is current and compliant with all regulatory requirements and guidelines related to ingredients, formulations, packaging, communications, including labeling, nutritional claims, allergen claims & product certifications. This role will support cross-functional teams including but not limited to QA, R&D, Marketing, Sales, Legal, etc.

PRIMARY RESPONSIBILITIES:

• Actively participate in the design of new product launches and changes by providing regulatory expertise on product formulation, package design, labeling, and claims development including mandatory nutrition labeling, nutrient content claims, health claims, ingredient declaration, serving size, allergen claims, product certifications, etc.
• Proactively understand and interpret regulatory requirements for product manufacturing, ingredients, formulations, labeling, claims, etc. and develop point of view on impact to the company.
• Work with R&D in creating final nutritional facts panel and ingredient statements for label, artwork, and communications.
• Review and approve regulatory components of ingredient & nutrition information documents, final packaging artwork, label copy, and research concepts for substantiation and compliance.
• Ensure regulatory compliance with food safety and food labeling as it relates to the FDA FSMA (21 CFR 101, 106, 107, 113, 117), FALCPA, Prop 65, USDA, GFSI, State regulations, as such and provide training as needed to necessary departments.
• Champion regulatory discipline with internal company functions, external partners, and lead changes as appropriate. Develop and implement related SOPs to streamline workflows.
• Perform assessments and develop pre-emptive and proactive plans as they pertain to emerging trends.
• Serve as the main point of contact for product certifications and related requirements such as Organic, Non-GMO, Gluten-Free, Kosher, Halal, and others as required. Manage securing and maintaining product certifications and related documentation.
• Collaborate with internal stakeholders and external legal/regulatory experts & consultants to build and manage the internal regulatory capabilities as needed for domestic and future international frameworks.
• Lead all regulatory efforts as the company expands into new markets in the US and globally through understanding and application of appropriate regulations.
• Participate in educational programs to do relevant trainings to keep abreast of the domestic and international regulations.

PERFORMANCE MEASURES:

• Customer Satisfaction – Meeting internal customer needs via precise and timely regulatory review and recommendations.
• Product – Accurate product claims, certifications, and compliance to current regulatory guidelines.
• Colleagues – Feedback from key internal and external work partners.
• Ownership – Internal regulatory subject matter expert.
  

SKILLS AND QUALIFICATIONS:

• Technical degree – Preferably Food Science, Food Law/Regulations, Nutritional Science, Dietetics, Chemistry, Applied Science, Engineering, or similar.
• Minimum of 5-7 years of regulatory experience in food/nutritional supplement industry.
• Capable of serving as a trusted advisor in achieving strategic regulatory compliance.
• Excellent understanding and knowledge of US food regulations related to quality, safety, and labeling.
• Hands-on experience in achieving product certifications.
• Ability to make independent educated judgments on correctness, accuracy, and appropriateness of information presented.
• Ability to prioritize and make decisions and recommendations that align with current regulations.
• Strong attention to detail, logical reasoning, and careful execution of tasks.
• Confident and articulate creative problem solver.
• Management skills to handle work scheduling, coaching, and process execution.
• Responsible for simultaneously managing multiple deadlines and projects.
• Ability to implement best practices and continuous improvement methodologies.
• Lead projects to facilitate cross functional continuity, provide exceptional support and streamline operations.
• Knowledge of word-processing, spreadsheet, computer programs, and database applications. Nutritional database experience is desired.
• Strong organizational skills & must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a high-profile and rapidly changing environment.
• Possess exceptional communication skills with a keen ability to listen, communicate (written and verbal), and ability to follow-up effectively with all staffing levels, co-packers, vendors, and customers.
• Safety-First Attitude.
• Be flexible and embrace change with a growing and evolving company.

Kate Farms cares well for its employees and it shows through the provision of standout benefits! Kate Farms provides amazing benefits such as Medical, Dental, Vision, Life Insurance, FSA, 401k Retirement Plan, Paid Time Off, etc. And if that didn’t excite you, our company pushes the envelope further by extending our benefit offerings to Parental Leave, Remote Work options and many other outstanding company perks.