• Define scopes of work, review technical proposals, and review execution of external hazards analyses by both internal engineering teams and external contracting firms. • Manage progress on external hazards analyses, regulatory submittals, and licensing support. • Ensure integration of external hazard assessments (e.g., seismic, flooding, and meteorological phenomena) into the overall licensing strategy and design-basis evaluations. • Identify and assess potential safety challenges posed by external hazards early in project development, and recommend mitigation measures or design modifications. • Track changes in NRC regulations (e.g., 10 CFR Part 100, Regulatory Guides, NUREGs) and evaluate their impact on external hazards compliance strategy. • Develop and maintain regulatory strategy documents, white papers, and briefing materials that articulate the approach to addressing external hazard requirements. • Represent external hazards considerations in cross-functional planning and strategic meetings with internal stakeholders. • Oversee internal external hazards project management systems. • Collaborate with engineering, design, and licensing teams to incorporate hazard analysis results into probabilistic risk assessments, safety evaluations, and licensing deliverables. • Review deliverables from constructors relevant to external hazards. • Coordinate the preparation and review of responses to NRC requests for additional information (RAIs) related to external hazards topics. • Author, edit, and finalize technical reports, regulatory filings, presentations, and licensing documents using modern documentation tools and best practices for clarity and consistency.

• Lead development of labelling strategy for new products and/or label revisions for existing active marketed products, by collaborating with cross functional teams during clinical development, regulatory submission and launch • Supports Lundbeck Product Labeling Committee activities as LPLC reviewer/Deputy Chair, coordinating and collaborating with LPLC Chair, GSL Team and cross functional partners to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance • Provides competitive labeling intelligence and insights to communicate initial labeling frameworks and regulatory expertise to address labeling challenges during development and post-approval maintenance of global labelling activities, ensuring cross functional communication and execution per process • Partners with cross functional teams providing labeling expertise and regulatory knowledge to author and develop competitive and optimal target product labelling, CCDS, EU SmPC, USPI, CPM, Carton and Container and other labelling materials required for marketing registration that aligns with Organizational business strategy and regulatory requirements • Ensures effective planning and execution of all cross-functional labeling activities to maximize timebound high quality deliverables • Responsible for the implementation and compliance management of the Company Core Data Sheet, in conjunction with Global Strategic Labelling team and cross functional support • Liaises with CFTs to support labeling related Information requests from Regulatory bodies regarding label content and labeling change requests • Provides high-level RA advice and identifies regulatory requirements for labeling development and compliance to proactively advise on risk mitigation strategies for labeling submissions • Assesses supporting information to support label language against regulatory requirements • Maintains awareness of global regulatory legislation and assesses impact to active marketed, established marketed and development products/programs • Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory)

• Serve as the primary point of contact for providers and internal teams regarding telehealth regulations, DEA requirements, PDMP, licensure, prescribing standards, and internal Medical Operations policies • Interpret regulatory and policy requirements and provide clear, practical guidance that supports compliant care delivery without unnecessary escalation • Identify recurring questions or areas of confusion and proactively recommend SOP updates, training needs, or workflow refinements to reduce operational friction • Lead initial investigation, triage, and resolution of operational, clinical, or compliance-related issues raised by providers, support teams, or internal stakeholders • Act as a trusted operational partner to providers by ensuring timely, accurate responses to day-to-day questions impacting workflows, documentation, prescribing, and care delivery • Directly supervise and manage the Provider Administrative Support Team, including offshore or overseas administrative assistants, in partnership with HR • Maintain and continuously improve Medical Operations SOPs, decision trees, and escalation protocols in alignment with current regulations and internal standards • Participate in a rotating weekend on-call schedule to support operational continuity and timely issue resolution

• Develop, implement, and maintain HR compliance policies, processes, and Standard Operating Procedures (SOPs). • Maintain the company handbook, state supplements, and standalone policies while serving as a subject matter expert on compliance-related matters. • Monitor and interpret state, local, and federal employment laws and advise HR and leadership on compliance requirements and legislative updates impacting Compensation, Payroll, Benefits, and HR practices. • Lead employee relations matters for office and remote employees and support escalated cases within fulfillment center HR. • Research, recommend, and support implementation of compliance-related training for employees and leaders. • Conduct audits to ensure required employment disclosures and notices are delivered across the employee lifecycle. • Ensure compliance with leave, disability, and employment regulations, including FMLA, ADA, PFL, FLI, STD, LTD, EEO, and applicable labor laws. • Partner with internal stakeholders to support compliance reporting and analytics, including EEOC reporting. • Manage Visa and immigration processes, advising candidates and employees while ensuring policy and regulatory compliance. • Partner with external counsel on immigration strategy, case management, and regulatory compliance. • Oversee Employer of Record (EOR) vendor relationships and support international employees throughout the employee lifecycle. • Track visa case activity, documentation, and expiration timelines while coordinating communications across stakeholders. • Manage relationships with external counsel and compliance-related vendors. • Support special projects and additional compliance initiatives as needed.