Compliance

• Collaborate, build relationships and communicate requirements across the organization
• Identify and work with others within the organization to improve reporting data
• Collaborate with Regulatory Reporting colleagues to ensure efficient and effective reporting
• Ensure the maintenance of procedural documentation for the regulatory reporting process
• Analyze results and provide insightful detail to management for trends and fluctuations
• Lead and participate in quality control efforts to ensure information used and reported is consistent

Regulatory Reporting Data – Automation Manager

• Oversee the implementation and ongoing interpretation of Medicare laws, regulations, and regulatory guidance, ensuring timely and accurate execution across impacted business areas.
• Serve as a subject matter resource for inquiries and lead responses to audit and data requests from regulators, auditors, and internal oversight partners.
• Interpret regulatory guidance, assess compliance gaps, identify root causes, and design and implement sustainable corrective action plans.
• Routinely communicate project status, risks, and outcomes to senior leaders and executive stakeholders, translating complex regulatory requirements into clear, actionable business guidance.
• Oversight of new and updated regulatory guidance implementation, leadership of Annual Enrollment Period (AEP) readiness activities across multiple business areas, proactive identification and mitigation of operational risks, and end-to-end coordination of audit and regulatory responses.
• Contributes to regulatory compliance, operational stability, and overall member satisfaction.

Senior Manager, Medicare Business Compliance

• Manage market conduct exams and regulatory inquiries
• Interact with state regulators and drive successful implementation of corrective action plans
• Provide subject matter expertise on state regulatory environment to business areas and compliance teams
• Coordinate market conduct exams across business areas and with Legal
• Serve as a point of contact for state regulators and third-party auditors
• Ensure accurate, timely collection and delivery of exam materials
• Oversee responses to exam findings and corrective action plans
• Maintain strong documentation of all exam-related work

Manager, Corporate Compliance – Market Conduct Exams

• responsible for the review and approval of all US promotional materials
• serving as the promotional regulatory expert with legal, medical and commercial colleagues
• serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB
• propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts
• provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs
• support the US commercial teams by participating in strategy discussions and providing regulatory guidance
• provide promotional regulatory input on concepts and draft materials
• actively participate in labeling and global regulatory team meetings
• maintain current awareness and understanding of FDA advisory correspondence and regulations
• ability to take on more complex projects and provide promotional regulatory training and coaching to team members

Assoc Director, Regulatory Affairs – Advertising and Promotion

• 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.

• Classify new US import items accurately using HTS codes and prepare binding ruling requests for products requiring Customs guidance
• Support US import compliance strategy by maintaining classification data, broker communications, KPI tracking, and related compliance programs
• Facilitate import clearance by working closely with customs brokers, US Customs, and internal partners to ensure timely and accurate entry filings
• Advise QRG brands and stakeholders on customs compliance matters, including classification, FTAs, FDA product codes, and other agency requirements
• Audit customs entries and resolve post-entry issues, including corrections, broker follow-up, and responses to Customs inquiries such as CF28/29
• Contribute to duty savings and special projects through tariff engineering, free trade programs, regulatory research, SOP development, and ad hoc analysis

Customs Compliance Specialist

• 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

• Delivers compliant, risk-based solutions that help the organization achieve its goals
• Independently influences internal business partners regarding the programs supported
• Drives and executes against compliance strategies and roadmaps
• Advises and engages in complex compliance matters
• Analyzes complaint themes and actions appropriately
• Champions compliance programs and educates business partners
• Applies strategic thinking to develop appropriate solutions to mitigate regulatory risks

Compliance Consultant

• 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

• Collaborate and coordinate with applicable internal stakeholders to evaluate local and regional requirements for packaging, product chemical assessment, etc.
• Perform all necessary reporting activities (across all relevant business units) related to local and regional requirements.
• Proactively monitor regulations relevant to our products and packaging, to ensure regulatory compliance of products and processes, and be ready for state/province reporting requirements.
• Provides regulatory and strategic guidance to local business partners for existing and new product regulations
• In alignment with relevant global stakeholders, implements regulatory solutions for the assigned product assortment
• Apply sound knowledge of international and local laws, regulations, standards and guidelines to the business, anticipating and communicating regulatory trends to ensure resilience of product innovations
• Contributes to creation, implementation and development of the regulatory strategy and regulatory processes within their regulated area
• Supports marketing and sales in development and approval of labeling and claims in compliance with applicable market regulations.
• Strong ability and willingness to learn specific corporate processes and procedures as they relate to corporate compliance of the company’s portfolio of professional hygiene and other products.
• Performs regulatory training, proposes and supports the implementation of process improvements and supports the creation and revision of standard operating procedures

Regulatory Affairs Manager – Regulatory Reporting

• Coordinating regulatory compliance efforts for PNC’s organizations, planning, developing, and implementing Compliance Program activities, and recommending and driving changes to the groups’ Compliance Program, including related policies, procedures, and controls on an ongoing basis with a preferred focus on our Public Finance business line
• Designing and implementing compliance monitoring activities over sales and trading practices
• Leading the communication and socialization of Compliance Program objectives in the Public Finance Line of Business Senior Management and other business partners
• Supporting key initiatives by analyzing data to identify compliance risks
• Assists in providing resolutions to manage and mitigate the identified risks
• If necessary, escalates identified risks to Line of Business Senior Management
• Identifies compliance impact on matters such as marketing materials, sales programs, product development, documentation review and other business initiatives
• Developing and delivering regulatory compliance training to personnel on an ongoing basis
• Monitoring, researching, and identifying regulatory, compliance, and industry developments for emerging risks, and evaluates and communicates the materially of the risks identified

Senior Compliance Program Advisor – Capital Markets

• Supports internal customers by assisting them to understand regulatory and other requirements, implement compliant solutions and establish adequate monitoring mechanisms.
• Receives, logs, researches, analyzes, and responds to compliance inquiries and concerns that are related to regulatory and other requirements and guidance, as well as other compliance issues.
• Administers the Incident Reporting and Corrective Action process to ensure that compliance issues are identified, addressed, and resolved on a timely basis, using an approach that prevents future reoccurrence of similar issues.
• Participates in projects or committees aimed at implementing operational, technological, and other changes to achieve or maintain compliance with regulatory and other requirements.
• Conducts oversight activities of First-tier, Downstream, and Related Entities (FDRs), Delegated Downstream Entities (DDEs) and/or CHIP subcontractors, as applicable.
• Develops, maintains, and oversees compliance monitoring activities and strategies.
• Provides support during internal and external audits, as appropriate, and monitors the completion of corrective action plans.
• Reviews, analyzes and evaluates regulations and guidance to determine its impact and affected business areas.
• Prepares, coordinates and/or submits required regulatory filings, attestations or reports.
• Develops and maintains internal departmental policies and procedures and provides recommendations to business areas in their development and implementation of their own policies and procedures.
• Administers or supports processes owned by the department such as Corporate Policy Administration, Conflict of Interest Disclosures, Compliance Training, Regulatory Intake, Compliance Monitoring and Exclusion Screening, among others.
• Performs other tasks as assigned by management, the Compliance Officer or the Chief Compliance Officer.

Compliance Specialist

• Oversee the daily operations, workload management, and performance of the Compliance Department, including State Compliance, Regulatory Affairs, and Licensing functions across all business areas of the insurance lifecycle.
• Manage and develop compliance supervisors, analysts, licensing personnel, and regulatory affairs staff, including coaching, accountability, quality review, and professional development.
• Monitor and interpret changes in insurance laws, regulations, bulletins, enforcement trends, market conduct expectations, and operational compliance requirements across multiple jurisdictions.
• Lead operational implementation of regulatory changes and ensure business processes, workflows, forms, communications, and operational procedures remain compliant with applicable regulatory requirements.
• Identify operational inconsistencies, process gaps, or regulatory exposures and develop standardized procedures, workflows, departmental expectations, reporting standards, and compliance controls across compliance functions.
• Partner with leadership and cross-functional stakeholders to provide operational compliance guidance, regulatory interpretation, and risk-based recommendations related to business initiatives and operational changes.
• Assist Compliance leadership in developing scalable compliance frameworks, departmental structures, governance processes, reporting standards, and long-term program initiatives.
• Serve as an escalation point for complex compliance matters, operational concerns, and cross-functional compliance initiatives while exercising sound judgment regarding matters requiring escalation to Compliance leadership.
• Support and participate in regulatory interactions, examinations, audits, and compliance-related meetings in coordination with Compliance leadership.
• Lead departmental process improvement initiatives and operational enhancement efforts to support organizational growth, efficiency, and regulatory readiness.
• Participate in broader enterprise initiatives and cross-functional projects outside the immediate compliance space, depending on business needs.

Compliance Manager

• Perform technology compliance and risk assessments across IT and cloud environments
• Evaluate control design aligned with regulatory requirements
• Assess cybersecurity and information security programs and governance
• Support AI and emerging technology risk assessments
• Work across 1st and 2nd lines of defense
• Develop an understanding of the industry leading frameworks and methodologies for NIST, PCI, HIPAA, SOC2, Sarbanes-Oxley, COBIT.

Senior Associate, Technology Compliance and Emerging Risk Consulting

• Review daily vendor delivery performance, ensuring all issues of non-compliance prior to and at the point of receipt are addressed
• Liaise with internal departments within the DC on all issues of non-compliance
• Initiate the correction processes of all ‘received’ non-compliant products through the Rework Coordinator both on site and through off site facilities
• Assess likely costs incurred and create chargebacks in line with policy advising Merchandising and vendors throughout the process
• Provide a central point of contact for vendors, merchandising, and Operations teams where all enquiries regarding compliance can be resolved
• Support / facilitate a smooth process for Vendor on-boarding, relating to Operational days for new and existing Vendors with regards to compliance including appropriate operational teams

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