Regulatory Affairs Specialist
Incorporated in 2013, Aurora, Colorado based MycoTechnology, Inc. is a food technology company that has developed a novel food processing platform using gourmet fungi to transform agricultural products by improving taste, value and nutritional characteristics. MycoTechnology developed the world’s first organic bitter blocker, ClearTaste™, which directly removes the need for sugar in foods by blocking the perception of unwanted taste, including bitterness, astringency, and other flavor defects in various food products. The largest food companies around the world are looking to use the technology to reformulate products to be healthier for consumers. ClearTaste™ is 100% natural, GMO free, chemical free, and certified organic. MycoTechnology recently introduced PureTaste™, a high quality, neutral tasting, complete vegan protein, that has the nutritional profile unlike any other protein on the market. Its PureTaste™ production facility will open in Q4 2018, creating over 60 new career opportunities.
Purpose of Position:
MycoTechnology is seeking a Regulatory Affairs Specialist to assist with domestic and international food and beverage regulatory work. This position reports to the Director of Regulatory Affairs. The individual will be responsible for independently providing our customers with product regulatory information in accordance with US guidelines, customer specific guidelines and various international regulations. This role supports all functions of the business to support innovation, mediate import export and provide a smooth process to market through multitude of processes and procedures. This is to be accomplished with the use of outstanding teamwork. Salesforce program support, internal information systems and in coordination with the R&D Stage Gate and Innovation Development, Sales Coordination, QA/QC groups, as well as the Regulatory Compliance Group at MycoTechnology headquarters.
- Drafting and coordinating responses to questions from regulatory authorities to obtain regulatory approvals in support of product launches in key markets.
- The Regulatory Affairs Specialist may provide support to the retrieval of regulatory codes that support business development needs and secure products successful launch to market. Including managing full NPD and launching processes.
- Provide support to customs, harmonized tariff numbers, international pre-notification imports, providing supply chain guidance when necessary for MycoTechnology supplies and finished products.
- To collectedly prepare customer documentation to satisfy customer requests. This function requires knowledge of specific customer and US FDA Food/Flavor & State Regulations. Specific documents include: customer questionnaires, natural certification, FDA/FEMA-GRAS Certifications, allergen, food-grade, and GMO certification, continuing food guarantee, country of origin, nutritional, organic, Kosher, Halal, country permissibility and other appropriate documents.
- Support management in other regulatory tasks, including special projects. Identify areas of improvement and increased efficiency.
- Update MycoTechnology’s BRC procedures for the continuous improvement process. Interface with Sales Team, Production, Quality Control and affiliates to satisfy customer requests.
- Review U.S. product labels (including ingredient statements, nutrition facts, nutrient content claims, health claims, and other statements provided on label for regulatory compliance.
- Acting independently to anticipate needs, studying issues, identifying options, and offering compliance solutions.
- Building effective relationships with key stakeholders, ensure effective communication, information flow, and effective issue-resolution.
- Preparing documents, executive summaries, and presentations to senior leadership and
- regulatory agencies to accomplish goals.
- Compiling, researching, managing and archiving information. Assist the Regulatory Team with process improvement and data management, including the development and maintenance of labeling checklists, brand reference guides and SOPs.
- Summarize and review microbiological data to meet regulatory reporting requirements.
- Monitor and track current regulations and warning letters related to food labeling, nutrition, claims and food safety.
- Collaborate and facilitate collaborations across multi-disciplinary teams.
- Organizing meetings and coordinating or leading the activities of others.
Knowledge, Skills & Abilities:
- College degree (B.S.) in Food Science, Food Technology, Food Chemistry, Nutrition or related fields
- 3 to 6 years of experience in the flavor and or food industry group.
- This position has detailed knowledge in regulatory issues and interpretation of regulations and legal affairs. Knowledge of basic chemistry and mathematics essential.
- Proficiency in submitting or supporting regulatory submission including FEMA FDA GRAS but not lined to 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 Product, SalesForce Client Management Systems and ERP like
- The ideal candidate will bring two years of regulatory experience and technical skills writing, GRAS submission writing preferred.
MycoTechnology is located in Aurora, CO. We offer a competitive compensation package and a full benefits package that includes 401(k), paid vacation, and paid holidays.