Compliance

• Advise internal stakeholders on implementation and development of SEC, CFTC and NFA swaps requirements
• Lead the development of relevant compliance program elements including policies and procedures, training, risk assessments, issues management, governance and management reporting
• Engage with the business, including Markets Financing Solutions, FX Sales & Trading, as well as Compliance, Legal, Operations, Enterprise Risk Management, Finance and Audit stakeholders
• Monitor and analyze the implementation of proposed and final rules promulgated by the CFTC, SEC and NFA on swaps and security-based swaps
• Assist in overseeing the Volcker Rule compliance program
• Provide regulatory guidance to management, business lines, and functions
• Respond to regulatory inquiries, audits, examinations and investigations, and liaise with regulators (SEC, CFTC & NFA)
• Develop training for Associated Persons to educate employees of their obligations and expected behaviors.

Vice President, Swap Dealer Compliance

• Provide strategic regulatory labeling expertise and operational leadership to cross functional teams
• Ensure the successful development of company core data sheets (CCDS), regional labeling, and target product labels
• Assist the Head of Labeling and Advertising in preparing for and facilitating interactions with the Labeling Decision Board (LDB)
• Develop labeling policies and standards, providing guidance and driving process improvement initiatives

Director, Global Labeling – Regulatory Affairs

• Lead end-to-end global monitoring of regulatory changes, guidance, and enforcement trends across key health authorities.
• Establish and execute structured surveillance processes across global regulatory intelligence sources.
• Monitor competitor and industry intelligence to identify emerging risks and opportunities.
• Assess and interpret regulatory changes for impact to products, processes, and business strategy.
• Lead triage and prioritization of new regulations and guidance, ensuring timely escalation and alignment.
• Prepare clear, leadership-ready intelligence reports and risk summaries.
• Develop and lead forums, dashboards, and communication mechanisms to disseminate regulatory intelligence across stakeholders.
• Define and track KPIs related to regulatory intelligence effectiveness and impact.
• Ensure consistent interpretation and alignment of regulatory requirements across functions.
• Collaborate with Regulatory Affairs, Quality, Medical Safety, and business partners to translate intelligence into actionable plans.
• Drive enhancements to the regulatory intelligence operating model (sources, cadence, tools, and governance).

Manager, Regulatory Intelligence

• Support and continually work within the parameters established by a risk-based Quality Management System framework
• Serve as the Customer Service (CS) Subject Matter Expert (SME) regarding SOX financial reporting, Quality and Compliance
• Assist CS Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes
• Lead and manage projects related to broader Supply Chain initiatives
• Provide CS Quality & Compliance expertise on applicable projects
• Support documentation management and departmental/Regional Change Control documentation
• Complete required compliance/assigned training by required due date

Quality Compliance Analyst

• Support and continually work within the parameters established by a risk-based Quality Management System framework.
• Serve as the Customer Service (CS) Subject Matter Expert (SME) regarding SOX financial reporting, Quality and Compliance.
• Assist CS Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes.
• Lead and manage projects related to broader Supply Chain initiatives, as required.
• Support change management strategies by applying change management principles and tools.
• Conduct lessons learned post-implementation and identifies opportunities to continuously improve.

• Lead end-to-end global monitoring of regulatory changes, guidance, and enforcement trends across key health authorities.
• Establish and execute structured surveillance processes across global regulatory intelligence sources.
• Monitor competitor and industry intelligence to identify emerging risks and opportunities.
• Assess and interpret regulatory changes for impact to products, processes, and business strategy.
• Lead triage and prioritization of new regulations and guidance, ensuring timely escalation and alignment.
• Prepare clear, leadership-ready intelligence reports and risk summaries.
• Develop and lead forums, dashboards, and communication mechanisms to disseminate regulatory intelligence across stakeholders.
• Define and track KPIs related to regulatory intelligence effectiveness and impact.
• Ensure consistent interpretation and alignment of regulatory requirements across functions.
• Collaborate with Regulatory Affairs, Quality, Medical Safety, and business partners to translate intelligence into actionable plans.
• Support regulatory strategy development, submission planning, and lifecycle management with forward-looking insights.
• Partner with digital and data teams to enhance intelligence tools, analytics, and reporting capabilities.
• Drive enhancements to the regulatory intelligence operating model (sources, cadence, tools, and governance).

• Fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies.
• Primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT).
• Accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives and setting clear expectations for Global Regulatory Strategy.
• Responsible for proactively contributing to the Target Product Profile (TPP) and ensuring competitive profiles in alignment with business objectives.
• Supervise, coach, and facilitate feedback culture within the GRT to develop team performance.
• Accountable for ensuring alignment and communication internally and externally as “one GRA voice” with TA, GBU Head and up to the GRA LT when needed.
• Identify opportunities to support the team in identifying regulatory acceleration opportunities, take thoughtful risks, and accept challenges.
• Monitor and interpret the global regulatory environments and ensure robust strategy by leveraging expertise in GRA (e.g. Regional experts).

Global Regulatory Lead

• Partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines.
• Solve problems creatively and strategically, and introduce innovative concepts to manage ad/promo projects.
• Imparts senior regulatory guidance and advice during issues management activities.
• Provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert.
• Continually monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends.
• Evaluates the impact on external environments and the business.
• Develops and implements regulatory strategies for marketed products within the product area.
• Mentor and develop others in executing strategy.
• Establishes and develops key internal relationships with therapeutic product leaders to foster open communication and teamwork.

Director, US Regulatory Affairs – Advertising and Promotion

• Serve as a regulatory representative on multidisciplinary program teams for one or more investigational products
• Contribute to the development and execution of global regulatory plans aligned with program objectives and development timelines
• Support regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle management
• Evaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning
• Partner closely with cross functional development team and program leadership to support development objectives and regulatory requirements
• Support the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements
• Independently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documents
• Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs

Senior Manager/Associate Director, Regulatory Affairs

• Independently prepare IND Modules for routine submissions
• Support regulatory affairs leadership in preparation of complex submissions
• Perform thorough independent background research through all pertinent search engines
• Ensure that documents appropriately evaluate and present data and methodology
• Navigate and obtain information for projects from all available resources
• Produce timely, scientifically accurate data summaries
• Construct documents in a manner consistent with applicable regulations and guidance
• Serve as Regulatory representative in department discussions
• Interface with international affiliates on regional regulatory strategy

Regulatory Strategy Associate

• Act as compliance liaison for assigned areas and assist with creating a culture of compliance through training, engagement and providing consistent feedback on compliance standards.
• Responsible for the identification, analysis, communication and resolution of advertising deficiencies, lead generation practices, agent conduct, and other compliance issues for assigned areas.
• Review life insurance and annuity marketing material for compliance with applicable regulations.
• Assist in the creation, implementation, and maintenance of compliance policies, procedures and educational material.
• Work with internal and external partners on vetting and implementing compliance and business initiatives.
• Participate in compliance projects, such as onboarding new technology, and serve as backup to other functions as needed.

Senior Compliance Analyst

• Lead the US advertising and promotional compliance strategy for assigned products
• Review US promotional and non-promotional/scientific material, attending review meetings and providing regulatory guidance
• Serve as primary contact for communications with the Office of Prescription Drug Promotion and/or Advertising and Promotional Labeling Branch for assigned products
• Provide training support on regulatory requirements for prescription drug promotion
• Provide advice to product development teams on advertising and promotion issues
• Maintain stakeholder awareness of proposed and newly approved labeling changes
• Collaborate with their manager and Medical Legal Regulatory Coordinator in developing processes and procedures
• Maintain regulatory expertise in product promotion compliance
• Communicate new regulatory standards to brand teams and management

Associate Director, Advertising and Promotional Compliance

• Leads the Regulatory CMC team responsible for our company's antibody-drug conjugates (ADCs) in late-stage development and life cycle management.
• Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs.
• Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.
• Ensures appropriate reviews, approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health Authorities.
• Provides critical review of major submission documents and response to Health Authority questions.
• Effectively communicates CMC regulatory strategy, risk, mitigation and overall plan to the GRACS, R&D, Manufacturing, GHH management team, product development teams, and executive management, as relevant.
• Establishes strong cross-functional and divisional partnerships to ensure collaboration with key stakeholders, customers and external organizations.
• Negotiates with and influences the opinions of others within and across the divisions and regulatory agencies.
• Represent GRACS CMC on key executive level meetings and leadership forums, as a delegate for the CMC Leadership Team member, as required.
• Actively engage as a Leadership Team member within the regulatory CMC department.
• Monitors changes in regulatory environment with potential strategic impact working closely with Regulatory CMC Policy.
• Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues.
• Evaluates key business challenges for products/programs within the biologics portfolio and collaborates with team members to direct the development of new and improved solutions.
• Develops plans to execute functional and divisional strategies and initiatives.
• Applies appropriate combination of perspectives (business, technical, global, etc.) when making decisions and generating solutions.
• Develops resource requirements and directs the allocation of the resources to meet regulatory CMC deliverables for the team.
• Works with R&D, Manufacturing, and GHH to prioritize work within the assigned biologics products to ensure effective support for the portfolio.
• Partners with R&D, Manufacturing, and GHH to ensure robust prioritization of work to meet agreed upon goals across the organization.
• Influences and drives development of innovative solutions to problems and ability to make rapid, disciplined decisions across divisions.
• Manage, coach, and develop CMC staff including performance management and advancement of personal and professional development goals to ensure the team is highly capable of regulatory CMC deliverables required for the biologics portfolio and they are developing broad regulatory CMC capabilities.
• Identify key talent and provide development opportunities that enable growth and retain talent.

Executive Director, Regulatory Affairs

• Supervise and support a team of Quality and/or Compliance professionals, ensuring effective execution of quality system processes.
• Ensure compliance with applicable regulations and standards (e.g., FDA QSR, ISO 13485, and internal quality policies).
• Lead and support internal and external audits, regulatory inspections, and customer audits, including preparation, execution, and follow‑up.
• Oversee investigation and resolution of nonconformances, deviations, CAPAs, and complaints, ensuring timely and compliant closure.
• Review and approve quality documentation such as SOPs, work instructions, protocols, and reports.
• Partner cross‑functionally to assess and mitigate quality and compliance risks related to manufacturing, suppliers, and product changes.
• Drive continuous improvement initiatives to enhance quality system effectiveness and operational performance.
• Coach, develop, and evaluate team members to build technical capability and leadership readiness.

Supervisor, Quality/Compliance

• Lead the creation, maintenance, and governance of global healthcare compliance policies and related procedures.
• Establish and oversee a robust policy lifecycle management process.
• Partner with legal, regulatory, and compliance teams to implement policies globally.
• Design and execute an Annual Global Compliance Awareness Training program for all employees across all regions.
• Implement a risk-based approach to targeted compliance training.
• Develop and manage a comprehensive onboarding training program for new Health Care Compliance Officers (HCCOs).
• Drive global compliance communications to create awareness and promote a strong culture of integrity and compliance.
• Manage and coach direct reports.
• Oversee third-party vendors and consultants involved in policy development, e-learning content creation, or communications.

Senior Manager, Compliance Policies, Training & Communication

• Conduct research and deliver strategic advice for risk management leaders
• Develop understanding of client requirements for successful risk management
• Conduct primary research on risk management capabilities
• Define the future of risk management
• Collaborate with research teams to develop comprehensive research portfolio
• Write and create multiple research projects annually
• Consult with clients to apply Forrester’s research
• Build industry presence as a speaker and thinker

Senior Analyst, Cyber Risk Quantification – GRC

• Monitor regulatory changes and assess the potential impact on the organization.
• Maintain EHS compliance programs aligned with national, regional, and local regulations and update, as necessary, to ensure compliance.
• Support sites globally relative to legal obligations, company requirements, and other obligations.
• Lead the internal EHS audit program including (1) auditor development/training, (2) scheduling, (3) executing, and (4) effectiveness for the globally organization.
• Collaborate with cross-functional teams to integrate EHS requirements into business processes and projects.
• Support EHS integration post M&A activities.
• Lead onboarding for new hired EHS professionals.
• Deliver training and awareness programs to promote compliance and safety culture.
• Develop key performance indicators (KPIs), data analytics, and execute trend analysis across the global organization.
• Implementing the EHS Framework program consistency across the globe with follow-on gap planning.
• Lead the global ISO14001 Environmental Management System certification and ISO45001 Occupational Health & Safety Management System and certifications.
• Respond to customer inquiries regarding environmental and safety practices.
• Analyze the effectiveness of the EHS program against business KPIs.
• Lead the identification of environmental risks & opportunities and work with other functional and operating teams to execute improvement plans.

Senior EHS Manager – Compliance Assurance

• Monitor for relevant regulatory developments across all 50 states and the SEC, ensuring timely awareness of new compliance issues, rule proposals, and comment periods.
• Develop and maintain XYPN’s advocacy and policy roadmap, including issue tracking, prioritization, engagement status, and next steps.
• Partner with the Managing Director and Executive Team to shape advocacy priorities and provide informed recommendations on engagement opportunities.
• Develop a deep understanding of XYPN member firms, industry trends, and emerging regulatory issues to inform advocacy priorities and identify opportunities to influence regulation.
• Develop consistent channels for gathering member feedback, case studies, and practical examples to inform XYPN’s advocacy positions.
• Coordinate member-facing communications regarding advocacy initiatives, regulatory updates, and policy resources.
• Partner with members to prepare for legislative or regulatory hearings, meetings with state regulators and legislators, and other advocacy opportunities, including testimony and supporting materials.
• Develop and deliver educational sessions for legislators, regulators, XYPN members, and industry groups on regulatory trends, RIA business models, operational realities, and the impact of proposed regulation.
• Build productive relationships with regulators, industry stakeholders, advocacy partners, and member firms to support ongoing dialogue and collaboration.
• Coordinate strategic partnerships with industry associations, including IAA, FPA, NAPFA, CFP Board, and other aligned organizations.
• Draft policy positions and supporting materials, including comment letters, white papers, policy briefs, issue summaries, case studies, and testimony.
• Lead execution of advocacy activity in individual states, with the SEC, and with NASAA, including preparing formal responses to proposed regulations, policies, and rulemaking initiatives.
• Represent XYPN in meetings with state and SEC regulatory staff, NASAA representatives, and other relevant stakeholders on advocacy and rulemaking matters.
• Attend industry conferences, regulatory events, hearings, symposia, and working groups to strengthen relationships and stay engaged in evolving policy conversations.
• Accountable for reporting on activity and impact related metrics ranging from: Policy issues being tracked, Comment letters submitted, Meetings with regulators, Evidenced impact on policy changes.

Director of Policy and Regulatory Affairs

• Oversee export shipment operations ensuring strict compliance with applicable authorizations
• Prepare, review, and file export declarations with precision
• Conduct systematic audits of export declaration records
• Monitor, track, and report on trade compliance activities
• Develop and deliver training on export shipment processes
• Support senior ITC team members in preparing authorization applications
• Process requests for export license exemptions applying sound regulatory judgment
• Maintain comprehensive records in alignment with U.S. Government regulations
• Identify opportunities for process and procedure improvements
• Collaborate on projects and initiatives as part of cross-functional teams

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