• 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

• Identify the sustainability metrics we need today and will need in the future. • Set up simple, repeatable ways for teams to provide sustainability data. • Investigate inconsistencies, get to the root cause, and help teams fix them. • Turn raw ESG numbers into clear insights for reports, filings, external communications and internal decision-makers. • Keep track of new reporting rules and update processes when they change. • Lead interactions with auditors, supplying data, explanations, documentation, and evidence trails. • Run materiality assessments and refreshes. • Design ESG control frameworks: control objectives, requirements (evidence, approvals, frequency, responsible owner) and specific control activities for each material topic. • Develop sustainability-related policies that teams can understand and actually use.

• Oversee compliance functions across the organization • Lead internal investigations into fraud, waste, abuse, and misconduct • Ensure adherence to Anti-Kickback Statute, Stark Law, and False Claims Act • Collaborate with senior leadership to maintain a cohesive approach to growth • Establish a transparent 'Speak Up' culture for compliance reporting