• Own and manage the adverse action pipeline, ensuring compliance with ECOA requirements, timely issuance of notices, and accurate tracking and documentation for audit and regulatory review. • Review and respond to compliance tickets through Freshdesk (or similar system), providing clear, accurate guidance and ensuring timely resolution and escalation when needed. • Prepare and maintain exam-ready loan files and support documentation for internal audits, regulatory exams, and third-party reviews. • Support and monitor compliance audits, including tracking findings, assisting with remediation efforts, and ensuring timely follow-up on corrective actions. • Identify potential compliance risks through daily activities and escalating issues or recommend process improvements to management. • Follow established compliance procedures, job aids, and regulatory guidelines in all assigned tasks. • Perform other related duties as assigned.

• Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities • Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations • Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure • Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams • Serve as primary interface with ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé), industry groups, and trade associations • Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations • Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements • Monitor status of submitted regulatory activities and ensure timely completion • Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions • Ensure timely submission of renewals and mandated post-approval applications • Maintain RIMS database with current local activity and track compliance KPIs • Oversee compliant labelling (RCP, Notice, packaging) including updates, translations, and promotional material review • Act as primary RA representative for local Commercial Operations (ComOps) • Support regional regulatory TA teams within GRA for efficient planning and submission preparation • Collaborate with Global Labelling for Foundational Labelling Processes

• Lead Local Regulatory Responsible (LRR) overseeing LRRs for effective decision making and smooth operations • Act as the first escalation point for LRR challenges • Focus on local regulatory requirements and Health Authority national engagements • Interact with local external stakeholders e.g. Health Authorities, Local industry association(s) and Regional Regulatory Leads

• Lead and support the full NIST RMF lifecycle for Onebrief deployments, on-prem or cloud-native, across multiple security boundaries • Maintain, and review authorization packages, including SSPs, SAPs, SARs, POA&Ms, STIGs, and supporting artifacts • Coordinate internal assessments and readiness checks ahead of external audits • Partner with Engineers, Product teams, and Security leadership to integrate compliance requirements into system design and operations • Provide guidance on secure architecture and control implementation • Track regulatory changes and advise leadership on compliance implications • Conduct periodic risk assessments and suggest appropriate risk treatment actions • Develop internal cybersecurity awareness and training presentations for employees • Conduct supply chain risk management assessments for current and future vendors