Senior Regulatory Affairs Specialist
Our client is an international leader in the development of spice and herb extracts, natural flavors, colors and antioxidants, modified hop extracts, dry products and nutritional ingredients for the manufactured food, beverage, nutritional and pharmaceutical markets! We have been retained to find a talented Senior Regulatory Affairs Specialist. This role will be based in Kalamazoo, Michigan.
This role will provide regulatory and technical product support for internal and external customer requests and anticipated potential issues. Interact with customers daily to provide information for them to comply with applicable food laws. Ensure that company's products comply with government regulations and laws as well as religious dietary laws pertaining to the manufacture of food ingredients. Work with global, federal, state and local regulatory agencies and personnel on specific matters affecting food ingredients. Advise company on the regulatory trends and patterns that could affect operations. Train others on internal process and collaborate within company to ensure effective and compliant practices are in place.
- Timely and accurately fulfill regulatory compliance requests from internal and external customers. Report product information using standard templates to satisfy customer inquiries. Understand current regulatory issues to anticipate and address potential issues.
- Research and develop company statements in response to regulatory and quality requirements from customers and in response to industry events. Compare proposed company statements against other records and standards, verifying consistencies and accuracy.
- Collect and use data on departmental performance to make recommendations for continuous process improvement.
- Accurately maintain product information databases.
- Review and respond to customer specification requests according to procedure.
- Manage process of Kosher and Halal certification.
- Support TTB filings and other TTB related activities.
- Help establish and maintain procedures and processes to assure regulatory compliance and participate in audits of these procedures. Train regulatory and other employees on best practices and ensure that employees understand relevant regulatory information.
- Monitor product changes to assure compliance with domestic and foreign regulatory requirements. Execute customer notifications according to procedure.
- Maintain current knowledge of existing and emerging regulations, standards and guidance documents.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Develop ingredient statements for all new products. Accurately review and verify ingredient information of existing products.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Review raw material and ingredient compositions for regulatory conformity based on industry guidelines / international restrictions.
- Bachelor’s degree in scientific or legal fields (Chemistry, Biology, Nutrition/Food Science, Criminal Justice)
- Minimum 3 years of regulatory experience in the food or beverage manufacturing industry (FDA or USDA)
- Demonstrated ability working in teams to manage quick turnaround times in high volume, high variety, open office environment while meeting aggressive deadlines.
- Strong organizational and computer skills.
- Strong interpersonal skills. Demonstrated ability to work in a professional manner with customers and co-workers by telephone, e-mail and in person and ability to work with other departments to complete requests.
- Must be detailed and accurate with strong demonstrated proof reading and reference checking skills.
- Experience with research and investigation of quality and regulatory questions, concerns and preparing professional, potentially legally-binding, written responses.
- Be able to travel roughly 15%.