Dedicated and experienced product life cycle management, food regulatory affairs and nutrition labeling professional with over 12 years of experience in food industry. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals and achieve company goals. Proactive in developing effective processes and executing regulatory affairs initiatives for food industry. Assisted new product development in meeting regulatory requirements. Maintained regulatory information dossiers and submissions. Knowledge of manufacturing processes. Familiar with research and development, marketing and customer service standards.
Skills
Product Lifecycle Management
Food & Nutrition - Regulatory Affairs & Product Development
Regulatory Compliance and Documentation
USDA & FDA Regulations
Submission Coordination
Document Quality
Software - DevEX PLM, Genesis, Blue Label, EZ Form, TraceGains, Microsoft Office.
Specification data bases and other nutritional databases
Project Specifications
Company Quality Standards
Product and Service Knowledge
Standard Operating Procedures
Records Management Systems
Time Management
Dietary Supplements
Work History
Product Lifecycle Management System Administrator , 05/2021 - 03/2022 Ken's Foods, Inc. – City, STATE,
System admin for Product Lifecycle Management (PLM) System including ingredient management, packaging management, formula management, finished product management, regulatory management and new product development.
Coordinated with management and product development teams to plan, develop, coordinate and execute product lifecycle management strategies aligned to Kens Foods vision, mission and purpose.
Supported implementation of PLM system software applications to enable centralized management of PLM tasks.
Developed product documentation to communicate and align key components of upcoming features and products to internal teams.
Liaised with vendors to develop deep understanding of business needs.
Assessed vendor products and maintained positive vendor relations.
Coordinated design meetings and decisions across internal departments and teams from research and development, quality, purchasing, supply chain operations, and information technology.
Maintained Product Data Management (PDM)- including food safety data
Served as internal subject matter expert (SME) for PLM including configuration management, product quality management, requirements management, design management, product compliance and product portfolio management.
Collaborated with business line management to identify and prioritize new concepts for development and launch.
Regulatory Affairs Manager - R&D, 03/2018 - 04/2021 Ken's Foods, Inc. – City, STATE,
Managed all regulatory affairs and adhered to state and federal requirements for salad dressings and barbecue sauces including ingredients, formulas, labeling, and packaging.
Worked with internal team members (research and development, legal, marketing, sales, and quality assurance) to accomplish regulatory goals and achieve full compliance with all products.
Managed labeling and nutritional software, Genesis and other nutritional databases.
Managed team responsible for graphic design and packaging project management.
Built and maintained specification databases.
Consulted with regulatory representatives and consultants to manage filings, applications and reports.
Assured compliance with all set criteria, to include Kosher, Halal, Non-GMO, and Organic certification programs.
Consolidated global information relevant to and monitored global submissions and approvals status.
Performed and documented quality control checks to maintain compliance with company initiatives.
Prepared and maintained document inventory for core dossier preparation in collaboration with research and development team.
Managed Genesis and Blue Label software to create product technical file packages for product compliance certifications of food and salad dressing products.
Directed documentation efforts to comply with domestic and international regulations and standards.
Provided responses to regulatory agencies and consultants regarding product information of new and reformulated products.
Implemented regulatory guidance and product labels of meat and poultry products compliant with USDA requirements.
Prepared and submitted regulatory file applications and supporting documentation for label compliance with USDA requirements
Implemented regulatory guidance procedures for ‘All Natural’, ‘Organic’, or Health claims on labels.
Consolidated ingredient and labeling information and monitored submissions and approvals status.
Prepared and maintained document inventory for core dossier preparation in collaboration with quality assurance, vendors and consultants.
Assisted with regulatory product compliance initiatives such as direct to consumer products.
Led product teams of Graphic designers for regulatory product compliance on meat products.
Maintained and archived regulatory paperwork.
Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
Wrote or updated standard operating procedures, work instructions or policies.
Provided pre-, ongoing, and post-inspection follow-up assistance to USDA governmental inspectors.
Audited existing labels on ongoing basis and implemented corrective actions.
Compliance Associate, Regulatory Affairs, 07/2008 - 07/2010 Indigene Pharmaceuticals, Inc. – City, STATE,
Assisted with regulatory product compliance initiatives for dietary supplements
Consolidated global information relevant to dietary supplements and monitored global submissions (Canada as natural health products and other markets as food supplements)
Ensured compliance with labeling, promotional material, GMP requirements and quality standards.
Kept up to date with changes in regulatory legislation and guidelines and obtained pre-marketing permissions for dietary supplements.
Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
Prepared and maintained document inventory for core dossier preparation in collaboration with business development.
Maintained dietary supplement products requirements for adverse event reporting and its related notifications.
Developed and implemented standards, methods and procedures for inspecting imported dietary supplements.
Drafted and revised Standard Operating Procedures.
Maintained document control system.
Supported QMS function and its operations
Analyzed product complaints and made recommendations regarding compliance.
Performed and documented quality control checks to maintain compliance with company initiatives.
Education
Ph.D.: Food Technology And Processing, Expected in 2007 - Punjab Agricultural University - India, GPA:
Master of Science: Food Sciences And Technology, Expected in 2003 - Haryana Agricultural University - India, GPA:
Bachelor of Science: Applied Sciences And Food Technology, Expected in 2001 - Delhi University - India, GPA:
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