Senior Regulatory Affairs Specialist
Imbibe is seeking a Senior Regulatory Specialist to become the newest member of its growing Regulatory Team. 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.
- Gather and analyze the necessary data to ensure compliance with domestic (FEMA GRAS, FDA) and international (Health Canada, JECFA, GCC, Mercosur, EU, Australia, Mexico, APAC, EMEA) regulatory requirements for flavors on active customer projects as part of the risk assessment review
- Product Data Sheets, and ingredient declaration for flavors
- 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
- Ability to interpret rules set by governmental and certifying organizations including, but not limited to Non-GMO Project verification, 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.
- Familiarity with using Compliance Cloud
- Provide regulatory support to the internal R&D team and external customers – filling out questionnaires, Regulatory document requests (palm oil statement, Trace Gains suitability forms, etc)
- Assist with regulatory audits
- Develop and maintain company SOPs
- Ability to provide trainings to technical and non-technical teams and customers as necessary on relevant Regulatory topics
Qualification and Requirements:
- Bachelor’s degree in chemistry, biology, food science, nutrition, or other related fields
- 5-7 years of relevant industry experience in product safety and regulatory affairs in the flavor/food industry
- Excellent understanding of 21CFR101.22 and 7CFR205
- Working knowledge of US, Canadian and EU flavor regulations is strongly preferred
- Strong organization skills, and ability to prioritize work load independently. Be a Team Player
- 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 cross functional collaborative environment
· Demonstrate excellent verbal and written communication skills
· Strong Microsoft Office skills
Imbibe is the leading innovator in the beverage industry – we set the standard! Our clients benefit from our holistic approach to product development where we engineer every beverage from the bottom up. We design custom components, such as ingredient blends, flavors and finished beverages for every project. Imbibe combines a powerful synergy of innovation, technical expertise and dedication to ensure our clients never settle for anything but the best. To learn more about us, check out our website at www.imbibeinc.com.
You are eligible for healthcare packages after 30 days of employment. All healthcare plans are Affordable Care Act compliant, and we have several plans to meet a variety of needs!
Simply put, we are beverage experts. Our industry focus gives us a greater degree of insight into the beverage and flavor world!
We have a 40,000 sq. ft. facility that houses state of the art equipment, labs and a pilot plant.
At Imbibe, in addition to your job, you’ll have opportunities to step away and challenge a coworker to a game of ping pong or visit at the custom beverage bar. People should like where they work, and we strive to provide an environment that fosters creativity and friendship.
Imbibe is an equal opportunity employer and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. This transmission is intended only for the designated recipient(s), and any duplication or distribution, in any form or part, without the written consent of the sender is strictly prohibited. These confidentiality protections apply even if you received this transmission in error, in which case you should delete the message, disregard its contents and notify the sender of the mistake.