• Reporting to the Director, Global Regulatory Affairs, the Senior Manager, Regulatory Affairs role will integrate regulatory strategic development, submission management expertise, and hands-on execution to support the IND/CTA stage of development through NDA/MAA. • Contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). • Manage the preparation, submission and internal review and approval of regulatory documents, including providing technical regulatory input for global documents to streamline development. • Ensure current, innovative, and compliant regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA. • Participate as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved • Support preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.) • Provide regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning) • Ensure collaboration with and coordination of cross-functional project teams for timely execution of regulatory submissions, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight • Support regulatory operations during the regulatory submissions handoff process, as the primary point of contact for external publishing vendors, ensuring submission packages are accurate, formatted correctly, and validated. • Maintain the regulatory information system and ensure proper archiving, searchability, and accessibility of regulatory content including correspondence with regulatory agencies • Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned. Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate • Ensure compliance with internal SOPs, regulations and applicable laws. Drafts and reviews Regulatory Affairs SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required

• Work remotely, 5-days a week, handling all post-closing compliance audit and review activities. • Review closed loan files for completeness, accuracy, and compliance with investor and regulatory standards. • Identify, track, and resolve post-closing compliance conditions, exceptions, and deficiencies. • Prepare and correct documents such as Post Consummation Closing Disclosures and Cover Letters as needed to ensure compliance with company and investor guidelines. • Communicate with borrowers and third parties to resolve post-closing issues and obtain missing documentation. • Ensure timely delivery of response documents to compliance findings. • Maintain accurate records by scanning and uploading documents into the loan origination system.

• Conduct assurance activities related to the annual SOX Compliance audit with a specific focus of IT General Controls and Vendor SOX Compliance. • Lead compliance activities for the NIS2 Directive, including performing initial and recurring gap assessments, remediation tracking, and supply chain security alignment. • Perform quarterly compliance assurance testing and maintain audit-ready evidence documentation. • Document compliance testing evidence and results providing audit ready assurances. • Maintain Management Action Plan (MAP) catalog with due dates. • Manage monthly audit Management Action Plans (MAPs). Includes the timely communication of open MAPs an escalation as needed of risks to completing MAPs at their agreed delivery dates. • Perform administrative activities in GRC Solution for compliance related activities. • Manage ad-hoc external IT audits. • Support GRC Lead for CTO/CISO focused internal audits. • Manage compliance program reporting activities.

• Provide daily operational and functional support for PLM and related Regulatory and R&D tools. • Act as a primary point of contact for system questions, issues, and troubleshooting related to workflows, configurations, and system behavior. • Escalate and coordinate system issues with internal technology teams or external vendors as needed. • Support system releases, testing, and validation from a business-process perspective. • Support and reinforce standard business processes within PLM and connected systems across Regulatory, R&D, PD, and Product Innovation teams. • Help users understand system functionality, data flow, and best practices without directly creating or maintaining core data. • Identify process gaps or system limitations and partner with stakeholders to propose functional improvements. • Work closely with Data, Regulatory, R&D, PD, Product Innovation, and Master Data teams to ensure systems support end-to-end product lifecycle needs. • Serve as a liaison between business teams and technical teams, translating business process needs into functional system requirements. • Collaborate primarily with global stakeholders. • Assist with ad-hoc reporting requests and system inquiries related to PLM, formula and regulatory workflows. • Support visibility into product formula, and compliance statuses through system outputs and reports. • Document system workflows, support processes, and known issues to improve consistency and user adoption. • Contribute to continuous improvement initiatives focused on system usability, process efficiency, and regulatory readiness. • Compile Dossier & PIF for Regulatory Teams