Rachel Denk Email & Phone Number

Bloomington, Indiana, United States

Bloomington, Indiana, United States

Beloit, Wisconsin

TRAINING• Develop, coordinate, and manage training programs for cross functional business partners and other global teams pertaining to strategic Regulatory initiatives• Lead trainer for new hires and team membersCOMMUNICATION• Proactively identify issues, program requirements, industry changes, and potential areas of improvement for programs• Representive in negotiations and discussions with the key industry regulatory decision makers, trade associations (FEMA), and government authorities (TTB, FDA)• Manage projects to ensure product and process compliance with customer requirements, industry practices and regulation changesSOFTWARE/PROCESS IMPLEMENTATION• User testing for PLM software upgrades and optimizations• Collaborate with IT programming team in developing PLM software functionality• Assist users on ways of working and trouble shooting in PLM, ERP and CRM systems• Regulatory lead for development, training, and implementation of corporate processes and workflows

Beloit, Wi

Beloit, Wi

Wheeling, Il

• Established Regulatory Department in company structure• Owned the development and launching internal Regulatory business training program (R&D/Applications, Sales/Customer Service, and Procurement departments)• Enhanced and managed government formula registration/approval programs and audits, such as TTB and USDA National Organic Certification Program (NOP)• Evaluated and completed customer requests (external and internal), including in-depth questions, product documentation, questionnaires, and approval of customer specifications• Analyzed and controlled new product formula and ingredient status

Geneva, Il

• Enacted regulatory upgrades in PLM system for regulatory parameters and data• Developed and integrated internal Global Compliance protocol for Regulatory Affairs and R&D departments to meet global customer requirements• Maintained government formula registration/approval programs, such as TTB, FDA Drug Master File, Natural Health Products Directorate, Australian Register of Therapeutic Goods, DEA restricted-chemicals exempt-registration, and USDA Organic certification• Completed customer requests (external and internal), including questions, documentation, questionnaires, and approval of customer specification contracts

B.S., Chemistry

Activities and Societies: Chemistry Club (2001-2003)Organic Chemistry, Analytical Chemistry, Inorganic Chemistry, Biochemistry, Physics.

Certificate, Business Administration, Completed

•Strategic Management •Marketing Management •Operations Management •Human Resource Management •Financial Management