• Support compliance onboarding for new products, features, and major engineering changes • Review control design and operational readiness prior to Go-Live • Partner with Product and Engineering teams to identify SOX-relevant risks • Provide clear guidance to teams on control expectations • Execute deep-dive testing of high-risk SOX controls • Perform root-cause analysis when issues are identified • Work directly with Engineering, Product, and Finance partners to support remediation of control gaps • Track recurring issues and surface systemic risks to leadership

• Investigate and analyze manual referrals and automated alerts stemming from transaction monitoring systems • Conduct due diligence research and KYC reviews on transaction activities across internal and external tools to assess legitimacy and mitigate risks. • Document findings and create written narratives to support case investigations. • Recommend case decisions based on investigative results in line with regulatory requirements and best practices • Identify patterns or emerging risks • Collaborate with cross-functional teams to evaluate, refine, and optimize compliance workflows, models, and procedures. Focus on improving efficiency, efficacy, scaling resources, and introducing industry best practices. • Act as a subject matter expert for new and existing Compliance Operations tools, processes, and future enhancements. • Test compliance tools, rules, and/or detection models, providing actionable feedback to technology machine learning teams. • Remain current with industry standards and developments in the areas of KYC, BSA/AML, and OFAC, and apply regulatory requirements and internal policies and procedures to case investigation • Maintain detailed documentation to demonstrate compliance with regulations and internal policies and procedures

• Lead the planning and preparation of standalone CMC submissions and response to health authority (HA) inquiries • Define submission strategies and content; identify regulatory approval risks and propose mitigation plans • Provide authoring support as needed • Review CMC components of relevant documents and contribute to content development as appropriate • Represent Regulatory CMC in cross-functional meetings and collaborate with internal and external stakeholders on assigned projects • Partner with Quality and other functions to assess the regulatory impact of proposed changes to clinical materials and commercial products • Stay current with international and domestic regulatory requirements and best practices • Provide guidance on interpreting and implementing regulations, guidelines, company procedures, and working practices

• Monitor & Analyze: Track global regulatory changes, guidance documents, and policy trends across key markets (FDA, EMA, PMDA, etc.) or stakeholders (EU Commission, ICH, ISO, etc.). • Impact Assessment: Liaise with relevant internal stakeholders and evaluate the implications of regulatory updates on the client's development programs and operational practices. • Stakeholder Alignment: Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness with key areas of interest and hot topics. • Communication: Contribute to the creation of and distribute internal newsletters, alerts, and briefing documents tailored to various audiences. • Publish relevant selected content to internal Engage forum. • Precedent Searches: Contribute to preparatory research and drafting of responses to precedent searches requests from various stakeholders. • Knowledge Management: Maintain a centralized repository of regulatory intelligence resources and ensure accessibility across teams. • External Engagement: Participate in industry forums, working groups, and regulatory intelligence networks to stay ahead of emerging trends.