• Enabling customers to make the world healthier, cleaner and safer • Join global Regulatory Affairs department, Reg Science team • Lead discussions, coordinate regulatory strategies globally on assigned clinical trials • Provide innovative solutions and global regulatory expertise • Act as liaison with internal and external clients • Arrange, lead, and report on client and regulatory agency meetings

• Responsible for delivery of site activation readiness • Prepare submission dossier for authorities • Provide regular updates on submissions • Maintain project plans and regulatory tools • Partner with site CRA for communication

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF. • May support the clinical team performing Pre-Study Site Visits.

• Oversee compliance with state gaming regulations, internal controls, and licensing requirements across multiple jurisdictions. • Act as a subject matter expert on gaming regulatory requirements and compliance frameworks, advising stakeholders across the business. • Design, implement, and continuously enhance regulatory compliance frameworks, policies, and procedures. • Align regulatory requirements with operational processes and business initiatives to ensure seamless execution. • Serve as a primary point of contact for gaming regulators, supporting audits, inquiries, and examinations. • Lead regulator engagement strategy, including preparing for and managing meetings and communications. • Partner with Product, Engineering, Operations, and Legal teams to embed compliance into new product launches and features. • Provide clear, actionable compliance guidance to support business initiatives and market expansion efforts.