• Lead execution of the compliance program charter, annual plan, and maturity roadmap in partnership with ERM leadership, Legal, and other key stakeholders. • Provide practical compliance guidance and implementation support to business leaders and teams, coordinating closely with partners to align with applicable laws, regulations, and organizational standards. • Design, deliver, and maintain core compliance program elements, including role-based training, policy communications, risk-based monitoring, and compliance dashboards. • Lead an enterprise-wide policy inventory and cleanup initiative, establish and operate the policy governance framework, and partner with Legal and other business functions. • Own the compliance hotline, ensure privacy-related concerns are appropriately managed and tracked, and produce regular analytics on allegations and outcomes. • Implement standardized enterprise issue management and coordinate with Internal Audit and Quality to align findings management.

• Responsible for delivery of site activation readiness • Preparation of Clinical Trial Application Forms and submission dossier • Interaction with CA/EC for study purposes • Regular updates about CA and EC submissions to Start Up Lead

• Develop and carry out a risk-based internal audit plan for IT operations, security controls, and compliance processes • Conduct audits from planning through reporting, evaluating the effectiveness of IT controls, policies, and procedures • Identify control gaps and IT-related risks during audits • Prepare clear audit findings reports and work with stakeholders on remediation plans • Work closely with IT, Security, Engineering, and other teams to gather evidence and facilitate audit processes • Serve as a liaison with external auditors and internal teams • Support external compliance audits and certifications • Maintain comprehensive audit workpapers and documentation repositories using a modern GRC tool • Help build audit playbooks and improve audit workflows • Stay up-to-date on industry best practices and emerging regulations

• 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 CA, EC, 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 as relevant. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • 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 collaboration. • Prepare. review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Forms. • Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. • Maintain communication with other key functions participating to country start up i.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.