• Assist in performing document formatting per Shionogi standards for submission related documentation. • Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files. • Provide support to the Regulatory Operations team. • Provide general assistance to the Regulatory Affairs department as needed.

• Lead the Regulatory Operations - Documentation Specialist team in overseeing the documentation processes within an organization, ensuring that all documents are accurate, compliant, and efficiently managed. • Involve in improving documentation workflows, and ensuring regulatory compliance. • Include document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. • Archive correspondences to and from the health authorities and internal and external GRM archiving. • Provide direction and support to the documentation team, ensuring high-quality work and adherence to standards. • Train team on documentation standards, procedures, and tools to ensure consistency and compliance. • Ensure all documents meet the organization's quality standards and regulatory requirements. • Continuously enhance documentation processes to improve efficiency and productivity. • Maintain document control processes for proper classification, indexing, distribution, and archiving. • Work closely with other departments to gather information and ensure comprehensive documentation. • Manage and support team members that ensure all correspondences to and from the health authorities are archived within the company’s system and comply with regulatory standards and guidelines.

Role Description Promote and support retail food safety programs and policies; teach, coach, and consult to drive compliance and strengthen Food Safety Culture. Partner with stores and operational area leadership to ensure compliance with regulations and company policies. - Provide in-store food safety support - Apply in-depth knowledge of food-handling, pest control, chemical, and audit programs - Maintain collaborative relationships with store leaders and operational area leaders - Act as a liaison between stores and regulatory agencies - Assist with new store launches - Participate in an after-hours & weekend on-call rotation - Up to 75% overnight travel - Engage with professional organizations and industry groups - Maintain professional credentials Qualifications - Knowledge of retail food code and regulations governing grocery retail at local, state, and federal levels - Knowledge of Microsoft Office including Outlook, Word, and Excel - Bachelor's degree in Food Science or related field - Relevant experience in retail operations or retail food safety management - Maintain or obtain NEHA Certified Professional – Food Safety (CP-FS) or Registered Environmental Health Specialist / Registered Sanitarian (REHS/RS) - Ability to work collaboratively with stakeholders - Ability to communicate complex information in a clear, concise, and organized way - 2 to 6 years’ experience in food safety compliance as related to food retailing or food processing - Demonstrated success in teaching or training others Benefits - Comprehensive health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans) - EAP, Mental Health Support, Medical Advice Line - Flexible Spending Accounts - Adoption and Surrogacy Reimbursement coverage - 401(k) matching - Paid time off - Parental leave

• Executes quality and compliance processes across the organization and facilitates the tracking and reporting of quality and compliance activities • Responsible for planning, monitoring, and reporting on quality and compliance for selected clinical trial delivery processes to determine adherence and understanding of ICH GCP requirements and processes • Contributing member of an independent team focused on clinical trial delivery quality assessment for ongoing operations and processes within supported functional areas • Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives • Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance • Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes • Ensure compliance with own Learning Curricula, corporate and/or GXP requirements • Represent GCP Compliance in meetings as needed • Performs other duties as assigned