Senior Regulatory Affairs Specialist I

About Imbibe

Imbibe is a dynamic, high-growth food and beverage development company based in Niles, Illinois. We specialize in developing, creating, and manufacturing beverage flavors, ingredient systems, and finished food and beverage products. Our mission is to design ingredients with impact for the food and beverage industry.

Since our founding in 1963, Imbibe has been at the forefront of flavor innovation and product development. We offer a comprehensive range of services, including full product development, taste modulation, and finished product solutions. Our state-of-the-art campus features an Innovation Center and Pilot Plant that enable us to tackle industry-wide taste and texture challenges, ensuring that our clients receive the highest quality products.

At Imbibe, we pride ourselves on our entrepreneurial spirit and commitment to continuous improvement. Our values of collaboration, accountability, and entrepreneurship drive us to deliver exceptional results for our clients. We also believe in giving back to the community. Through various initiatives we support efforts to combat food insecurity in the Chicagoland area by donating ingredients and our time.

If you're passionate about the food and beverage industry and eager to make a meaningful impact, Imbibe is the place for you. Let's create something extraordinary together!

Summary of Position
The Senior Regulatory Specialist will provide support to internal and external customers in order to ensure that all domestic and global regulatory requirements and compliance needs are fulfilled according to legal and corporate guidelines. The ideal candidate is a detail oriented and highly organized individual who is comfortable working in a fast-paced, high-energy environment with changing priorities.

Essential Job Duties

• Generate, review, and approve labels for finished products and flavors to ensure accuracy and compliance with legal standards.
• Gather and analyze the necessary data to ensure compliance with domestic (FEMA GRAS, FDA) and international (Health Canada, JECFA, GCC, Mercosur) regulatory requirements for flavors and finished goods.
• Review Nutrition Facts Panels, Supplement Facts Panels, Product Data Sheets, production labels and ingredient declaration for flavors and finished goods.
• Conduct risk assessments to evaluate the regulatory implications of proposed product changes or new ingredients.
• Review and analyze data provided by suppliers of new and existing raw materials; ensure that data entered in internal formulation software is accurate.
• Stay up to date on regulatory changes and understand the implications to the business related to these changes.
• Lead conversations with internal and external partners regarding regulatory recommendations
• Ability to interpret rules set by governments and certifying organizations including, but not limited to GMO, Bioengineering, Kosher, Allergens, Halal, Prop 65, Organic.
• Identify regulatory challenges relevant to commercial opportunities and serve as a subject matter expert by collaborating cross-functionally to solve them.
• Provide regulatory support to the internal R&D team and external customers.
• Assist in the development of marketing claims for new product concepts.
• Assist with regulatory audits.
• Prepare product statements and respond to customer requests.
• Develop and maintain company SOPs.

Minimum Qualifications

• Bachelor’s degree in chemistry, biology, food science, nutrition, or other related fields.
• 5+ years of relevant industry experience in product safety and regulatory affairs in the food industry.
• Excellent understanding of 21CFR101 and 7CFR205/206.
• Ability to make educated judgements on authenticity, accuracy, and appropriateness of information.
• Must be able to prioritize and provide input on regulatory aspects
• Must continually demonstrate a very strong attention to detail, careful execution of tasks, and regularly check own work before any submission.
• Flexibility, methodical and rigorous spirit. Ability to work in a collaborative environment.
• Demonstrate excellent verbal and written communication skills.

Preferred Qualifications

• Working knowledge of US, Canadian, EU & Mexican, and other international markets 

Working Conditions

• Office setting (hybrid)

Compensation & Benefits

The salary range listed represents the expected earnings for this role. The low end of the range reflects the starting salary for candidates with less experience or qualifications that meet the basic requirements for the position. The high end of the range reflects potential earnings for candidates with extensive experience, specialized skills, or qualifications above the standard requirements for the role.

Imbibe supports employee well-being and professional growth by offering a comprehensive benefits package that includes the following: 

• Comprehensive medical, dental, and vision care
• 401k retirement plan with company contribution and match
• FSA and HSA account
• Generous company holidays, PTO, and sick time
• Onsite gym and wellness opportunities 
• Paid parental leave
• Life and disability insurance
• Learning and professional development opportunities