• The Compliance Manager is responsible for ensuring that audit and corrective action processes are efficient, operationally sound, and proactively managed. • This role requires frequent collaboration with stakeholders at all levels of the organization to identify risks, resolve issues, and support a culture of compliance. • Provide guidance and training to audit staff, and ensuring compliance with auditing standards. • Lead and oversee a team on execution of all aspects of regulatory and client audits, including: Pre-site deliverables, Mock audits, On-site logistics, Written responses to audit findings and corrective action plans. • Interface with external clients and regulatory bodies to address inquiries, and support audit or examination activities. • Prepare and assist with monthly metrics reporting, including reporting to oversight committees and boards. • Monitor team performance, provide regular feedback, and support continuous improvement initiatives. • Research, interpret, and communicate applicable regulatory and contractual requirements.

• Oversee the creation, governance, and maintenance of all product, operational, and compliance related materials. • Implement a scalable strategy ensuring accuracy, consistency, version control, and accessibility across teams. • Standardize templates, processes, and tools to support internal operations and customer-facing content. • Ensure product, processes, and delivery align with regulatory requirements and support product adoption, regulatory & client audits, and client quality & compliance needs. • Lead the development and execution of Zelta’s quality management strategy, aligning it to organizational goals and regulatory expectations. • Establish and evolve quality processes, including audits, CAPA, SOPs, and quality metrics. • Create and maintain compliance frameworks in alignment with GxP , FDA/EMA regulations, ISO standards, and other relevant guidelines. • Conduct ongoing analysis of regulatory changes and market dynamics to ensure Zelta remains audit-ready and future-proof. • Implement clear goals, KPIs, and accountability structures to drive operational excellence. • Partner with cross-functional leaders to embed quality, compliance, and best practices throughout the organization. • Work closely with Product and Engineering to ensure new product releases meet quality and compliance standards, supported by robust documentation. • Partner with Operations and Customer Success to ensure quality and compliance programs support client satisfaction and readiness for audits or regulatory submissions. • Collaborate with Finance and the GM to ensure the quality and compliance roadmap aligns with business priorities and resource planning. • Establish scalable systems for product lifecycle management, compliance tracking, and quality reporting. • Implement continuous improvement programs to enhance process efficiency, reduce risk, and improve product and operational quality. • Serve as a subject-matter expert and spokesperson for quality and compliance matters internally and externally.

• 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 • 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 • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM

• Follow appropriate regulatory guidelines and templates • Assist with assessing client efficacy data (data gap analysis and preliminary risk assessments) for the active substance and/or product dossiers under the focus of appropriate and specific regulatory requirements • Review and check raw data and statistical analyses to prepare / produce data summaries for insertion into dossier's • Assist with preparation of summary tables in required format, interpretation and assessment of scientific / biological data together with a detailed critical assessment to assure scientific rigor, accuracy and clarity of presentation of results • Format and compile dossiers within agreed time schedules • Assist with validating strategies to assist clients in dossier preparation including experimental programs according to European and national data requirements