Eleni Chechopoulos

Director of Regulatory Promotional Operations - Oncology @Publicis Health

Chicago, IL, US

Responsible for carrying out the planning, scheduling, and coordination of submission obligations. Manage the interface between Regulatory Operations vendors, including definition, planning, implementation of the collaboration, as well as day-to-day vendor oversight and budget management. • Manage assigned projects and closely collaborate with personnel from Regulatory Science and other departments at Day One (as with vendors), to coordinate and implement high quality submission output. Accountable for the management of submission projects, including the preplanning, tracking, assembly, submission, and archiving of regulatory documents• Identified appropriate resources/business strategies to support submission publishing activities, including research of improved electronic document management systems and publishing tools• Collaborated projects with stakeholders by meeting regularly to identify and resolve open issues and to assess quality, delivery, and effectiveness, while developing opportunities for business process improvement• Maintained the submission-tracking process in support of short and long-term submission and resource planning• Initiated standard Operating Procedures, Work Instructions, and Workflows for the Regulatory Operations function. Ensured that Company’s practices are within the latest health authority and industry submission standards• Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents to ensure that documents meet requirements as “Approved for Submission”• Interacted and negotiated with the FDA and other regulatory agency in interpreting and implementing electronic standards related to eCTD and other submission formats. Source, manage and disseminate Regulatory Guidance pertinent to submission standard cross-functionally