MycoTechnology helps the food industry create healthier products without excessive sugar, salt, and fat by working with the natural transformative power of mushrooms to make new-to-the-world food ingredients. Their flagship product, ClearIQ™, is the world's first organic bitter blocker and flavor clarifier that helps cleanup the taste of functional ingredients and is a powerful tool in the fight against sugar and sodium. FermentIQ™ protein filled the void in the plant-based protein market, creating a complete plant protein with improved nutrition and functionality.
The Regulatory Affairs Specialist is responsible for independently providing customers with product regulatory information in accordance with U.S. guidelines, customer specific guidelines and various international regulations. This role supports all functions of the business to assist innovation, mediate import/export and provide a smooth process to market through a multitude of processes and procedures. This is accomplished through outstanding teamwork by coordinating multiple systems and groups, including Salesforce program support, internal information systems, the R&D Stage-Gate and Innovation Development, Sales Coordination, Quality, and the Regulatory Compliance team.
- Prepare documents, literature, and regulation summaries to support the regulatory requirements for dossiers to successfully enter global markets.
- Draft and coordinate responses to questions from regulatory authorities to obtain regulatory approvals in support of product launches in key markets.
- Monitor and track current regulations and warning letters related to food labeling, nutrition, claims and food safety.
- Review U.S. product labels (including ingredient statements, nutrition facts, nutrient content claims, health claims, and other statements) provided on label for regulatory compliance.
- Utilize knowledge and experience with global and domestic regulations, guidance, and applicable statutes.
- Assist the Regulatory Team with process improvement and data management, including the development and maintenance of marketing and sales collateral and develop SOPs, as needed.
- Build effective relationships with internal and external stakeholders, ensuring effective communication, information flow and sharing, and effective issue resolution.
- Organize meetings and lead regulatory projects across multidisciplinary teams.
- Provide support to supply chain/shipping department on regulatory requirements related to customs, harmonized tariff numbers, international pre-notification imports, providing supply chain guidance when necessary for MycoTechnology supplies and finished products.
- Provide regulatory support to ensure successful launch to market according to Stage-Gate procedures.
- Support management in other regulatory tasks, including special projects. Identify areas of improvement and increased efficiency.
Other duties as assigned.
- Bachelor’s degree in Food Science, Food Technology, Food Chemistry, Nutrition or related field from an accredited institution.
- 3+ years of experience in the food ingredient and/or flavor industry.
- 2+ years of experience in regulatory issues and interpretation of regulations and legal affairs.
- Highly self-motivated and directed.
- Ability to effectively prioritize and execute tasks in a high-pressure environment.
- Excellent written and verbal communications.
- Ability to manage and influence relationships and engage team members with diplomacy and tact.
- Proficient in basic chemistry and mathematics.
- Proficient in submitting or supporting regulatory submissions, including FDA, FEMA, and international bodies.
- Superb organizational skills and high attention to detail.
- Demonstrated excellent judgment and common sense.
- Strong critical thinking, analytical and problem-solving skills.
- Desire to excel and grow within the Regulatory team.
- Ability to adapt to shifting priorities and manage multiple projects with competing deadlines.
- Proficient in MS Office Products (i.e., Word, Excel, PowerPoint and Outlook).
- 2+ years of technical writing experience in the regulatory arena, such as GRAS, NDIN or other submission writing.
- Supervisory Responsibilities:
- This job has no supervisory responsibilities at this time.
- Work Environment:
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually moderate.
- Physical Demands:
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to sit; stand; walk; use hands to finger, handle, or feel. The employee must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision.
Incorporated in 2013, Aurora, Colorado based MycoTechnology, Inc. is a food technology company that harnesses the metabolic engine of mushrooms, known as mycelium, to create novel ingredients that solve the food industry’s biggest challenges. Our innovative ingredients and transformative technology offer solutions for sugar reduction, food insecurity, sustainable protein, natural immune support, and much more. For more information, please visit www.mycoiq.com.