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.
· Draft and coordinate responses to questions from regulatory authorities to obtain regulatory approvals in support of product launches in key markets.
· 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.
· Update the company’s FDA, USDA, BRC, state and local procedures to support education partnership in compliance and affairs updates, ultimately designed to ensure a 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.
· Utilize excellent knowledge of and experience with FDA regulations, guidance, and applicable statutes.
· Act independently to anticipate needs, study issues, identify options, and offer compliance solutions.
· Build effective relationships with internal and external stakeholders, ensuring effective communication, information flow and sharing, and effective issue-resolution.
· Prepare documents, literature, and regulation summaries to support the regulatory requirements for dossiers to successfully accomplish accepted dossiers for business suitability goals.
· Compile, research, manage, and archive information. Assist the Regulatory Team with process improvement and data management, including the development and maintenance of labeling checklists, brand reference guides and SOPs.
· Monitor and track current regulations and warning letters related to food labeling, nutrition, claims and food safety.
· Collaborate and facilitate collaborations across multidisciplinary teams.
· Organize meetings and coordinate or lead the activities of others.
· 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.
· Support management in other regulatory tasks, including special projects. Identify areas of improvement and increased efficiency.
· Other duties as assigned.
Knowledge, Skills and Experience
· Bachelor’s degree in Food Science, Food Technology, Food Chemistry, Nutrition or related field from an accredited institution.
· 3+ years of experience in the flavor and or food 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 submission including FDA, FEMA-GRAS, 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) and SalesForce.
· 2+ years of technical writing experience in the regulatory arena, such as GRAS, NDIN or other submission writing