Drew Raley

About Drew Raley

I am a highly-qualified professional with a background in Federal Acquisition Proposal…

Experience

1. Regulatory Affairs Specialist

   Solvita

   Oct 2021 — Present · Kettering, OH, US

   Lead development and execution of the process that institutionalizes collaboration between Solvita QRA and Business Development teams, resulting in proactive preparation, submittal and tracking of regulatory submissions and process notifications, as required by domestic and international countries in which Solvita conducts, or desires to conduct business, including required licenses and/or any other required process/document(s) such as country standards, customer agreements, etc, needed to ensure regulatory requirements are met.• Lead all aspects related to Solvita regulatory licenses, certifications, registrations, and accreditation applications required to conduct or continue conducting business in targeted countries. This includes leading linkages within Solvita multifunctional teams to enable proper project planning and on time execution that matches budgeted volumes and sales.• Lead establishment of processes and procedures to ensure compliance with domestic and international regulatory submissions.• Create, organize, and maintain documents to facilitate timely regulatory submissions.• Monitor proposed legislation and regulations for possible impact/effect on the organization. Lead development & execution of communication processes, including risk assessment process.• Train on targeted regulatory compliance requirements and risks across the globe with influence around viability of new businesses based on possible regulatory requirement concerns.• Collaborate in development and execution of a market claim process that results in accurate review of labeling and other marketing material, to ensure compliance with regulatory requirements and maintenance of desired product classification. • Execute labeling material reviews to ensure accuracy and compliance with regulatory and accreditation requirements.• Support process and product development project teams to ensure compliance with applicable regulations/standards.• Provide risk management support.

Skills

• Film Production
• Financial Analysis
• Copy Editing
• Strategic Financial Planning
• Ap Style
• Research
• Database Design
• Teaching English
• Proposal Writing
• Teaching English as a Second Language
• Policy
• Talent Casting
• Technical Writing
• Financial Planning
• Statistics