Jennifer Shellenberger Email & Phone Number

• Management of Bioengineering project to align raw materials and finished products with 7 CFR 66 the National Bioengineered Food Disclosure Standard. Review documentation on file for existing ingredients, gathering sufficient vendor information for justification of final product determination• Member of Vital Proteins SAP Specifications Integration team. Review existing vendor documentation against Specification data, provide guidance on Ingredient breakdowns and additive purposes. Communicate inconsistencies and corrections to Specification author, review Specifications for compliance with regulatory bodies, while ensuring Ingredients Specifications capture all requirements based on finished product labeling.• Provide guidance to Technical team for Nutrition Data Review Project by evaluating raw materials prior to populating SAP. Assesses the accuracy of vendor nutritional data and work with and provide guidance to Specification Analysts as they enter data into SAP• Submission of Structure Function claims for Dietary Supplements to the FDA through the CFSAN Online Submission Module• Responsible for Supplement OWL Maintenance Project. Review existing data and labels, communicate pertinent information to Regulatory, Technical and Product Development Managers• Create ingredient statements for finished products and communicate any compliance issues to Vital Proteins. Developing a data resource for ingredient breakdowns to track and standardize ingredient information• Other responsibilities include meeting and communicating with vendors on documentation issues, providing recommendations to internal employees concerning any number of regulatory questions, drafting and implementing SOPs, compiling Website claims and working with Legal, Research and Development, Technical and other Regulatory personnel to help maintain proper substantiation on file

Hunt Valley, Maryland, Us

• Creation of documents for McCormick & Company, Inc. customers; including Nutritional Datasheets, Allergens, Ingredient Statements and Percent Range Breakdowns, Microbiological Hazard Treatment, Ready to Eat, High Priority Chemicals, Proposition 65, rBST & BSE reviews, Vegetarian, BE/GMO Documentation (to meeting upcoming USDA Bioengineering rule), Agriculture Product Information Sheets, FEMA GRAS review, Mock Labels and any other standard or non-standard regulatory requirement• Extensive training / assisting new Europe-based employees in all of the above documentation creation, provide CFR references, guidance procedures and recordings up to and including the explanation of complex formulations with every type of additive, chemical, processing aid and manufacturing process available• Domestic (non-global customers) First Time Order regulatory approvals; involving formula evaluation for possible TTB submissions, High Priority Chemical identification, Ingredient Statement, Nutritional completion, Allergens, Specification approval• Domestic Change Management regulatory approvals; range from ingredient substitutions, retitles, manufacturing instruction changes, shelf-life changes, inactivations. Check international status of formula and acceptability of replacement raw material, TTB check, and review of regulatory documents and agreements with customers, update documents where necessary and notifying customers of changes• Alternate supplier review and approval• Raw material substitution review and approval for formulas required for immediate production• Assisted Certifications team with formula review for Non-GMO Project Verification, completed FoodChain documentation and evaluated Organic compliance• Domestic and international vendor creation for North American location (Canada, United States, Mexico) and maintenance of related data; including location, contact information, tax withholding, bank information, transportation details, payment method and terms

Charlotte, Nc, Us

• Manage all areas of regulatory affairs and compliance for labeling of domestic and international products. Responsible for creating nutrition facts panels and ingredient statements, advising on allowable claims and reviewing labels for accuracy• Provide direction to Marketing on appropriate label claims based on a product’s ingredients, nutritional and health related variables, ensuring all claims are accurate and comply with regulatory compliance• Function as nutrition project lead preparing for federal changes to the nutrition facts panels• Remain current on Non-GMO Project Verification, Kosher, Halal, Roundtable for Sustainable Palm Oil and Organic regulations and requirements• Spearheaded the quality and regulatory responsibilities as a core team member of new Agile Product Lifecycle Management (PLM) implementation• Managed and directed team responsible for overall data consolidation activities for transferring existing information into PLM• Leader of Technical Documentation Specialists responsible for drafting, maintaining, routing raw material vendor documentation, raw material quality specifications, finished good specifications and recipe sheets for all manufacturing facilities• Standardized all ingredient and finished good documentation company wide, including formats for Raw Material Quality Specifications, Finished Good Quality Specifications, Batch Sheets and Oven Settings• Instituted approval process and communication of new and revised documentation to ensure consistent communication across the company, preventing critical departments being overlooked during process• Work with in house counsel to develop company protocol and strategy as it relates to maintaining regulatory compliance to ensure product claim substantiation/defense

Hunt Valley, Maryland, Us

• Responsible for proceduralizing regulatory activities for best practice standards. Creation, renewal and distribution of a wide range of documents to satisfy regulations and customer requests including Kosher, Nutritional (100 gram data), Material Safety Data Sheets, Percent Range Breakdown, Country of Original, generation and maintenance of Halal certifications• Approved First Time Order, New Product Creation, Raw Material Notification, Cancel/Supersede• Worked with Global Data Administration personnel to include Corporate Regulatory Services in the Kosher approval process for New Product Creation reports. Ensured appropriate religious, certification and regulatory documents are available prior to production• Selected by executive management as a member of McCormick’s Regulatory Issues group• Analyzed production and development systems to ensure data integrity• Documented standard operating procedures for Corporate Regulatory Services activities• Established strategic relationships with internal and external personnel to effectively facilitate aspects of job responsibilities• Consistently develops new strategies for optimization and implementation of changes to further consolidate activities• Participating member of the Consumer Product Division/McCormick Flavor Division Kosher Consolidation Committee • Improvement of filing system for all Kosher raw materials, formulas and finished goods to decrease opportunity for product distribution prior to approval and allowing upkeep of product certifications and development of submission/termination letter for changes to certifications• Creation label repository to provide electronic access for all company personnel• Development of department computer based filing system granting concerned individuals access to all information, such as Kosher forms, product charts, new finished goods timelines for approved products

• Complied departmental monthly statistical reports for Corporate Vice President of Global Quality and Biologics including graphic presentations• Prepared Annual Product Evaluation Reports which were submitted to FDA including retrieving and compiling technical data• Maintained and outlined corporate audit commitments, issued overdue notices, generated bi-weekly report on overdue tasks• Successfully developed and maintained Quality Assurance tracking database for Validation documents, reducing loss of key reports and improving retrieval time• Updated GMP Manual and informed Quality Assurance Director of changes to policies• Created and maintained departmental product specification Access database and established recall contacts• Developed supplier certification strategy• Generated Quality/Technical Agreements with Contract Manufacturing and Contract Testing Laboratories to meet Consent Decree requirements• Supported management with coordination and development of training. Assisted with design of lesson plans for Standard Operating Procedures and training presentations and designated as Train the Trainer associate

Master'S Degree, Regulatory Affairs Of Food And The Food Inustry

Food Sciences Fundamentals Certificate

Certification, International Food Law

Bachelor'S Degree, Anthropology And Geology