Compliance

• Independently plan, prioritize, and manage regulatory activities across assigned development and commercial products
• Develop and implement regulatory strategies supporting timely approvals, continued compliance, and company objectives
• Manage assembly and timely submission of INDs, BLAs, and other dossiers for biologics investigation and registration
• Assess priorities, identify regulatory risks and opportunities, make recommendations, and escalate significant issues with proposed solutions or mitigation plans
• Respond to changing regulatory requirements, health authority requests, emerging product issues, and shifting business priorities
• Maintain regulatory submissions in compliance with regulatory requirements
• Represent the company in dealings with the FDA and other regulatory authorities
• Serve as regulatory lead or subject-matter expert on cross-functional project teams
• Provide guidance across products, regulatory pathways, biologics, and combination products
• Maintain current regulatory knowledge and advise management of significant developments
• Contribute to improvements involving best practices and SOPs
• Interface with departments, CROs, and external vendors as needed
• Reports to the Director, Regulatory Affairs

Senior Manager, Regulatory Affairs

• Oversee residential lending operations, regulatory compliance, and continuous process improvement
• Lead assigned mortgage operations staff
• Ensure compliance with HMDA, ECOA, Fair Lending, flood insurance, and related regulations
• Manage HMDA data collection, validation, monitoring, and annual reporting
• Coordinate internal, external, and regulatory audit requests and corrective actions
• Oversee mortgage loan lock administration and mortgage pipeline management
• Manage secondary post-closing conditions, investor suspense items, loan purchase requirements, and investor delivery activities
• Manage gain-on-sale reporting and related performance metrics
• Conduct mortgage vendor analysis and monitor vendor performance
• Perform or oversee mortgage-related general ledger reconciliations
• Maintain underwriting authority for residential mortgage and consumer loans
• Conduct appraisal and second-decline reviews and provide guidance on complex credit decisions
• Own and maintain departmental policies and procedures
• Lead business process improvement across mortgage workflows
• Provide functional support for Encompass and other mortgage technology platforms
• Serve as the Bank’s designated MERS Officer
• Prepare management reporting on compliance, pipeline activity, secondary market delivery, operational performance, and risks
• Represent Retail Lending on internal committees, projects, and initiatives
• Support internal, external, and regulatory auditors
• Direct, develop, and manage team members; conduct evaluations and provide coaching
• Establish departmental goals, monitor metrics, and drive business objectives
• Lead talent acquisition, succession planning, employee development, process improvement, and change management initiatives

AVP, Mortgage Operations – Compliance Manager

• Provide strategic, tactical, and operational regulatory CMC support across therapeutic modalities and manufacturing technologies
• Support clinical trials, market registrations, and post-approval activities
• Apply CMC technical knowledge and regulatory expertise to develop and execute global regulatory strategies
• Ensure internal consistency, effective change management, and predictable regulatory outcomes
• Build productive relationships across research, development, manufacturing, quality, regulatory, and partner organizations
• Apply technical knowledge of CMC drug development and pharmaceutical manufacturing sciences across drug substance, drug product, and analytical areas
• Develop, implement, and maintain global CMC regulatory strategies
• Provide regulatory advice for development, manufacturing, and lifecycle planning decisions
• Evaluate regulatory impacts, identify risks, and develop mitigation options
• Lead preparation, review, and finalization of CMC documents for global regulatory submissions
• Resolve technical or operational issues affecting submission timing, regulatory compliance, or product supply
• Manage complex issues and propose risk-based regulatory solutions
• Build relationships across regulatory, research and development, manufacturing, quality, and regional teams
• Provide regulatory guidance and subject matter expertise to CMC teams
• Mentor and serve as a resource within the regulatory CMC community
• Incorporate regulations and guidance into processes, tools, templates, and training materials
• Contribute to internal policy development and discussions on emerging regulatory trends
• Participate in industry forums or working groups
• Lead or support cross-functional teams developing and executing global CMC regulatory strategies
• Review CMC development strategies, control strategies, and submission content
• Collaborate with manufacturing sites, technical experts, and quality organizations
• Support health authority interactions, briefing materials, and responses to questions
• Communicate regulatory strategies, risks, and recommendations to stakeholders
• Share regulatory knowledge, lessons learned, and best practices
• Contribute to corporate positions and responses to proposed agency regulations and guidelines

Advisor, Senior Advisor – Regulatory CMC

• Support Quality and Regulatory Affairs intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance
• Maintain the organization's Standards e-system, standards watchlists, applicable standards inventory, regulatory intelligence records, trackers, and supporting documentation
• Coordinate the Regulatory Change Notification process for changes affecting registrations, licenses, certifications, technical documentation, labeling, or regulatory commitments
• Maintain regulatory correspondence and supporting records
• Serve as the QARA subject matter resource for FDA Automated Commercial Environment (ACE) and FDA/CBP medical device import requirements
• Coordinate and maintain FDA ACE data for imported finished goods, components, raw materials, and other regulated articles
• Support creation, review, and maintenance of FDA-related master data in SAP ECC6, SAP MDG, or other enterprise systems
• Partner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation
• Support resolution of FDA/CBP import-entry issues, including FDA Notices of Action, entry holds, detentions, document requests, and other inquiries
• Monitor changes to FDA/CBP import requirements and coordinate assessment and implementation
• Serve as an administrative point of contact for Notified Bodies and regulatory authorities
• Track regulatory commitments, information requests, audit actions, and required responses
• Support regulatory inspections, assessments, and Notified Body audits
• Maintain regulatory trackers, databases, certificates, licenses, registrations, and related documentation
• Support preparation, compilation, formatting, and administrative processing of regulatory submissions and notifications
• Prepare routine regulatory status reports and metrics
• Escalate complex regulatory strategy, legal interpretations, significant commitments, reportability decisions, and novel or high-risk import matters

Regulatory Affairs Coordinator

• Provide global regulatory strategy and support as a member of multidisciplinary teams
• Manage regulatory processes from development through approval and ensure compliance with US and international regulatory requirements
• Represent Regulatory Affairs in project meetings and provide regulatory guidance to cross-functional teams
• Serve as regulatory affairs contact for external parties, including CROs and advisors, involved in global clinical trials
• Develop and implement global regulatory strategies for clinical-trial submissions and registration under applicable regulations and guidelines, including US FDA, EMA, PMDA, ICH, and ISO
• Plan, prepare, author, and/or review IND, CTA, BLA, NDA, and MAA submissions and related documentation
• Liaise with global health authorities
• Contribute to regulatory strategies that expedite development, maximize success probability, and mitigate risks
• Communicate project updates and risks to senior regulatory affairs management and organizational stakeholders
• Track regulatory commitments and deliverables and coordinate internal and external staff for timely submissions
• Coordinate and prepare responses to health-authority information requests
• Prepare meeting requests and briefing documents and coordinate teams for health-authority meetings
• Provide input into regulatory policies and procedures aligned with GxPs, guidance documents, and corporate objectives
• Monitor, analyze, and disseminate regulatory intelligence affecting development programs
• Participate in due diligence evaluations of potential in-license and partnering opportunities

Senior Director, Regulatory Affairs

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU
• Review CMC sections of regulatory submissions, interactions, and responses with regulatory agencies
• Work with regulatory colleagues to develop global regulatory CMC strategies and submissions
• Participate effectively on cross-functional teams
• Serve as the primary regulatory CMC contact for assigned products and projects

Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

• Lead and oversee Longroad’s Prevailing Wage & Apprenticeship compliance program across applicable wind, solar, and energy storage projects
• Develop, maintain, and continuously improve compliance processes, controls, documentation standards, and procedures
• Identify, assess, and monitor compliance risks, gaps, and exceptions and coordinate remediation
• Monitor regulatory developments and guidance and assess impacts on projects and compliance processes
• Serve as an internal subject-matter resource on PWA compliance requirements
• Partner with Tax, Legal, Development, Construction, Operations/Asset Management, Finance/Accounting, Procurement, and other teams across the project lifecycle
• Review EPC and other project agreement language for alignment with PWA requirements
• Coordinate with contractors and third parties to establish compliance expectations and obtain required information and documentation
• Identify contractor compliance deficiencies and support corrective actions and remediation
• Manage external consultants performing PWA compliance reviews
• Ensure applicable PWA reporting and tax return reporting requirements are completed accurately and on schedule
• Maintain complete, organized, and audit-ready PWA documentation
• Support reviews, diligence activities, audits, and inquiries related to PWA compliance
• Maintain documentation of compliance issues and remediation efforts
• Develop and independently manage a comprehensive PWA compliance calendar
• Coordinate between Longroad and external consulting firms
• Manage multiple compliance workstreams, priorities, deliverables, and deadlines
• Communicate compliance status, risks, issues, and required actions to stakeholders and leadership
• Build cross-functional and external relationships to drive accountability and timely resolution

Senior Manager, PW&A Compliance

• Oversee residential lending operations, regulatory compliance, and continuous process improvement
• Lead assigned mortgage operations staff
• Ensure compliance with HMDA, ECOA, Fair Lending, flood insurance, and related regulations
• Manage HMDA data collection, validation, monitoring, and annual Loan Application Register reporting
• Coordinate internal, external, and regulatory audit requests; track findings and corrective actions
• Perform or oversee flood reviews and translate regulatory changes into procedures, controls, and staff guidance
• Support mortgage loan lock administration and oversee mortgage pipeline management
• Manage secondary post-closing conditions, investor suspense items, loan purchase requirements, and investor delivery activities
• Manage gain-on-sale reporting and operational performance metrics
• Conduct mortgage vendor analysis and recommend operational enhancements
• Perform or oversee mortgage-related general ledger reconciliations
• Maintain underwriting authority for residential mortgage and consumer loans
• Conduct appraisal and second-decline reviews and provide guidance on complex credit decisions
• Provide backup underwriting support and guidance on credit policy, underwriting guidelines, and investor requirements
• Own and maintain departmental policies and procedures
• Lead business process improvement across mortgage workflows
• Provide functional support for Encompass and other mortgage technology platforms, including configuration, testing, issue resolution, and enhancements
• Serve as the Bank’s designated MERS Officer and complete required attestations, reports, certifications, and administrative duties
• Prepare management reporting on compliance, pipeline activity, secondary market delivery, operational performance, and risks
• Represent Retail Lending on committees, projects, and initiatives
• Support internal, external, and regulatory auditors
• Maintain NMLS&R registration and uphold SAFE Act responsibilities
• Direct, develop, and manage staff; conduct performance evaluations and provide coaching and feedback
• Establish departmental goals, monitor performance metrics, and drive business objectives
• Lead talent acquisition, succession planning, employee development, process improvement, and change management initiatives
• Review and approve employee timecards and time-off requests
• Adhere to Bank policies, regulatory standards, risk controls, and required training

AVP, Mortgage Operations, Compliance Manager

• Lead and direct hospital-wide quality improvement initiatives to enhance patient outcomes and satisfaction
• Promote a culture of safety throughout the hospital
• Oversee patient safety programs and ensure compliance with industry standards and regulatory requirements
• Ensure compliance with healthcare regulations, accreditation standards, and quality reporting requirements
• Monitor and analyze quality metrics, including readmission rates, infection rates, and patient satisfaction scores
• Lead or facilitate Root Cause Analysis investigations for significant adverse events
• Prepare reports for hospital leadership, regulatory agencies, and quality improvement committees
• Lead the development and implementation of continuous improvement initiatives to address emerging challenges and improve quality and safety

Manager, Radiology Regulatory Programs

• Monitor and track employee health compliance, including immunizations, TB screening and clearance, annual health requirements, occupational exposure follow-up, and return-to-work clearance
• Maintain accurate employee health records in Workday and Epic; reconcile discrepancies and support data integrity
• Generate reports, dashboards, and compliance updates for leadership, regulatory reporting, audits, and quality improvement initiatives
• Support Employee Health and Infection Control activities, including policy updates, staff communication, training support, documentation follow-up, and workflow improvements
• Coordinate employee leave of absence processes, including FMLA, Massachusetts PFML, short-term and long-term disability, personal leaves, medical leaves, and workers compensation
• Track and manage leave requests from initiation through return to work, including documentation collection, Workday entry, leave status updates, and compliance monitoring
• Coordinate workers' compensation claims from initial report through claim closure
• Track work status, restrictions, lost time, modified duty needs, medical documentation, and return-to-work planning
• Liaise between employees, managers, HR, Employee Health, and clinical teams
• Monitor leave and workers' compensation trends and generate compliance and process-improvement reports
• Support employees with benefits, leave, workers' compensation, and documentation questions
• Assist with audits related to leave administration, workers' compensation, and employee health compliance
• Maintain confidentiality and comply with safety, infection control, privacy, conduct, Joint Commission, legal, and regulatory requirements
• Participate in departmental and organizational activities, trainings, and meetings

Compliance jobs in Massachusetts