Susan Cheney Email and Phone Number
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Susan is an expert in the research, interpretation and implementation of global regulatory requirements for the food industry. With more than 20 years of experience of increasing brand value by integrating food safety, regulatory compliance, quality and risk management solutions in organizations, Susan has successfully worked with governments, NGO's and third party agencies to craft legislation, gain approval of novel food ingredients and obtain certifications to drive business growth. Susan can successfully identify and analyze an organizations critical business requirements, identify deficiencies and potential opportunities while developing cost-effective solutions for enhancing compliance strategies.
Prova Us
View- Website:
- provaus.com
- Employees:
- 11
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Director Of Regulatory AffairsProva Us Jan 2022 - Present
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Managing DirectorRegsults, Llc Sep 2011 - May 2022Www.Regsults.ComREGSULTS™LLC is an independent regulatory consulting firm providing providing strategic, innovative and results oriented compliance solutions for the food industry. Consulting Services include:Regulatory Analysis & Policy Development- Analyze and interpret rulings and policies of US and international agencies as they relate to clients products and procedures.- Develop compliance solutions for meeting Food Safety Modernization Act (FSMA) requirements by addressing specific client needs using expertise, best practices, and key industry drivers. Formulation Review & Label Development- Complete product formulation legality assessments, including ingredient and nutrition labeling development.- Represent clients to regulatory agencies for label approvals. Supplier, Specification and Customer Data Management Services- Manage raw material documentation, maintain relevant parameters and notify clients of changes to key parameters.- Create and maintain raw material and product specifications.- Respond to and manage customer inquiries for product technical data.Product Registrations, Health & Nutrient Content Claims Notifications- Serve as the subject matter expert to ensure accuracy and legality of product labeling and documentation.- Prepare dossiers for FDA approval of qualified health claims for food and new dietary ingredients.- Evaluate structure-function claims and prepare 30-day notifications for submission to FDA.Auditing Services- Audit data and documentation for compliance with applicable regulations and policies.- Audit vendors for compliance with FSMA Foreign Supplier Verification program and Voluntary Qualified Importer program requirements.Specialties include: Regulatory Compliance, Data Management & Validation, Food Safety, Quality Management & Improvement, Research, Change Management, Consulting, Auditing, Training, Program & Policy Development. -
Food Regulatory Specialist North AmericaSelerant Corporation 2011 - 2013Greater New York City Area• Assisted in system design, specification development, and design review for new and existing software systems.• Developed and maintained North American legislative data for food additives and ingredients for incorporation into a new line of software.• Worked with Engineering to integrate new regulatory calculations and updates into software products.• Promoted competitive positioning of software products and identified opportunities for growth.• Drafted, reviewed and approved validation and compliance documents supporting computerized systems, including those related to audit, performance, compliance evaluation, and validation.
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Director Regulatory AffairsMartek Biosciences 2008 - 2011• Managed and implemented the global approval strategy for novel ingredients. Received approvals in Brazil, China, Russia, Thailand, the United States and Vietnam, securing new commercial opportunities for food and beverage, nutrition and animal feed business units.• Served as liaison with global government regulatory agencies and trade associations to develop proactive positions to avoid adverse regulatory compliance conditions and support business goals.• Provided regulatory expertise to Legal, Clinical Research, Marketing, Sales and Research & Development. • Responsible for planning and developing regulatory strategy and policy to achieve marketplace acceptance of the company’s product portfolio.• Directed and maintained the submission of all product registration applications to government agencies, including Drug Master Files, GRAS petitions, New Dietary Ingredient Notifications, Investigational New Drug Applications and EPA Pesticide Registrations. -
Director Regulatory AffairsKerry Ingredients & Flavours (Formerly Mastertaste) 2003 - 2008• Responsible for compliance and communication with all government agencies, including FDA, USDA, EPA, DEA, TTB, OSHA, DOT, U.S Customs, Health Canada, Codex and relevant regulatory agencies in the European Union, South America and Asia.• Designed and implemented a C-TPAT program for company compliance and auditing of foreign vendors. Successfully achieved Tier II status with U.S. Customs.• Managed participation in a FEMA/CALOSHA consultation program for flavor manufacturers. Created employee safety, hazard communication and chemical handling policies and procedures.• Centralized and managed TTB formula submissions and drawback filings resulting in a 25% increase in formula and drawback filing approvals.• Designed a regulatory audit program and audited business groups for compliance with company policy, customer requirements and regulatory requirements.• Analyzed legislation and created standard operating procedures to assure all products comply with all local, federal and global product regulations.• Documented business processes and designed protocols to successfully implement product lifecycle management software at 13 locations within budgetary and project constraints.
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Manager Of Regulatory & Technical AffairsHeller Seasonings 2002 - 2003• Implemented and maintained labeling software to automate the creation of FDA and USDA compliant ingredient statements.• Evaluated raw materials for regulatory compliance in product formulations and organized information into a central database.• Managed an average of 500 customer technical inquiries per month with a ninety percent response rate within 24 hours.
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Regulatory SpecialistFis North America 1999 - 2002• Reviewed and approved new product development and imported flavor formulations for sale in the North American market.• Participated as the regulatory technical expert on project teams, planning regulatory strategy and promoting new and existing products through the regulatory process.• Assisted with process mapping and coordination of PLM system implementation tasks involving raw materials and product technical information.
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Director Technical & Regulatory AffairsNational Confectioners Association/Chocolate Manufacturers Association 1997 - 1999• Received proposed rules from FDA for establishing a white chocolate standard of identity and revising confectionery serving size reference amounts.• Created monthly newsletters and position papers to communicate regulatory and technical developments to membership, customers and operating groups.• Directed a task force to create industry practices for the labeling of milk protein residues in dark chocolate, leading to the review of product labeling options by senior FDA officials.
Susan Cheney Skills
Susan Cheney Education Details
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Hospitality Administration/Management -
Food Science
Frequently Asked Questions about Susan Cheney
What company does Susan Cheney work for?
Susan Cheney works for Prova Us
What is Susan Cheney's role at the current company?
Susan Cheney's current role is Director Regulatory Affairs.
What is Susan Cheney's email address?
Susan Cheney's email address is sc****@****tek.com
What schools did Susan Cheney attend?
Susan Cheney attended Florida State University, University Of Maine.
What skills is Susan Cheney known for?
Susan Cheney has skills like Food Industry, Food Safety, Gmp, Regulatory Affairs, Food, Ingredients, Product Development, Fda, Food Science, Cross Functional Team Leadership, Regulations, Commercialization.
Who are Susan Cheney's colleagues?
Susan Cheney's colleagues are Rachel Gooding, Maria Fiore, Sonu Paridwal, Rian Lucas, Michael Gopin, Colin Hawkes, Justin Demers.
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Susan Cheney
Aurora, Il4yahoo.com, cs.com, rasmussen.edu, skeensmcdonell.com3 +131470XXXXX
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4marathonoil.com, marathonoil.com, marathonoil.com, marathonpetroleum.com2 +141942XXXXX
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Susan Cheney
Greater Boston4gmail.com, gmail.com, medallionbank.com, medallion.com7 +131228XXXXX
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Susan Cheney
Pds & Membership Services Manager At National Wooden Pallet & Container Association (Nwpca)Springfield, Va
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