Compliance

• execution of closed loop audit and assessment programs , including Technology Supplier Audit and GxP system Periodic Reviews.
• providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas.
• compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
• assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
• reports to the Head, Med Tech & Emerging Compliance.
• Executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership.
• Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
• Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations.
• Works with Quality partners to establish corrective actions to address any identified gaps.
• Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs.
• Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
• Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions.
• Provide compliance input and final review of formal responses to health authority observations related to Enterprise Quality Compliance.
• Provides compliance subject matter expertise and support to Technology Quality and sector Business Partners related to GxP processes in the end-to-end technology areas.
• Proactively sense for opportunities and actively participate in compliance program development from the outset.

Lead Technology Compliance

• Analyze quantitative and qualitative data (e.g., health authority information and trade association updates) to identify trends, risks, and outliers, and translate findings into actionable insights with clear implications and recommended actions for stakeholders
• Prepare recurring and ad hoc reports, dashboards, and executive-ready presentations that effectively communicate regulatory intelligence insights to support decision-making
• Ensure data accuracy, integrity, and traceability through robust extraction, validation, and reconciliation processes, while maintaining standardized templates, definitions, and methodologies
• Partner with the Senior Director and/or Directors to define requirements, manage competing priorities, and deliver high-quality analyses on time while enabling consistent execution through cross-sector collaboration
• Apply approved AI and digital tools to enhance reporting workflows and support implementation of regulatory intelligence systems

Manager, Regulatory Intelligence

• execution of closed loop audit and assessment programs , including Technology Supplier Audit and GxP system Periodic Reviews.
• providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas.
• compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
• assist in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
• execution of closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership.
• Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
• Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations.
• Works with Quality partners to establish corrective actions to address any identified gaps.
• Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs.
• Maintain awareness of new and emerging technologies and regulatory requirements.
• Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions.
• Ensure timely and effective support is provided to J&J Operating Companies globally.
• Provides compliance input and final review of formal responses to health authority observations related to Enterprise Quality Compliance Expertise.

• Support clients in maintaining compliance with federal, state, and local environmental regulations
• Contribute to sustainability and environmental risk management initiatives across industries
• Partner with experienced consultants and subject matter experts to deliver high-quality project outcomes
• Play a hands-on role in field investigations and data collection that inform critical environmental decisions
• Help drive continuous improvement in EHS management systems and compliance programs

Consultant, Environmental Health and Safety – Compliance

• Contribute to the management of US regulatory activities associated with advertising and promotion of the company’s marketed products
• Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director
• Contribute to advise on the development of product messages and materials across multiple functional areas
• Assist with providing timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
• Assist with providing review of US and Global (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance
• Ability to collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal
• Contributes to the working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
• Assist with interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, assist with helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions
• Responsible for compliance with promotional material submissions to FDA on Form 2253
• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; help assess the potential impact of enforcement activities on the company policies
• Knowledge of process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies
• Knowledge of products/indications to help provide continuous Regulatory A&P support is provided to stakeholders
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
• Knowledge of the input provided during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
• Ability to understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising

Associate Manager, Regulatory Advertising & Promotion

• Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
• Assisting in coordination and preparation for Agency meetings and associated briefing document preparation
• Managing and tracking queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
• Providing representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
• Performing research to support the development of regulatory strategy for the assigned clinical development program
• Maintaining knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
• Exercising discretion and independent judgment in the performance of the duties described above

Associate Manager, Regulatory Affairs Strategy – Oncology

• Provide strategic direction and leadership for the Technology Compliance team, which acts as the SDLC and IT Controls subject matter experts.
• Hold full accountability for the service line’s resource management and talent development.
• Oversee IT GRC’s SDLC advisory service to enable IT customer success by making SDLC and IT Controls compliance simple to execute.
• Provide thought leadership and direction on the application of SDLC and IT Controls for emerging technologies and large company initiatives with technology components.
• Direct core operational compliance functions, including the Compliance Validation Service, IT Controls implementation, Compliance Issue management, and Infrastructure Oversight.
• Oversee the IT audit support function that serves as the primary liaison and facilitator for internal and external audits.
• Drive continuous audit readiness through robust controls assessments and preparation for internal audits and external inspections.
• Partner with risk and compliance technology teams to improve adoption of those tools and to provide valuable user feedback for continuous improvement.
• Drive policy and controls training and awareness programs across the IT enterprise to build a proactive culture of compliance.
• Build and maintain strong, collaborative relationships with key stakeholders across IT, Quality, Finance, and the business to ensure alignment on compliance objectives and risk posture.

Director, Technology Compliance

• Serve as a proactive, trusted advisor to business partners by delivering practical, risk-informed guidance that enables strategic objectives while appropriately managing compliance risk.
• Build a deep understanding of assigned business strategies, priorities, and operating models to provide practical, risk-informed guidance that supports innovation, growth, and successful business execution.
• Proactively engage business teams early in strategy development and initiatives planning to identify opportunities, anticipate compliance considerations, and help shape practical solutions before execution.
• Exercise sound judgement in ambiguous situations by balancing business objectives, patient impact, regulatory expectations, and organizational risk tolerance.
• Embed principles-based decision making into business activities by applying sound judgment and aligning guidance to risk, rather than prescriptive rules.
• Assess emerging compliance risks and translate policy requirements into practical guidance that enables timely business execution.
• Drive execution of compliance initiatives, action plans, and cross-functional deliverables, ensuring high quality execution, accountability, and measurable progress against business and compliance priorities.
• Lead or support the HCC Framework inclusive of risk assessments, HCC projects, risk-tiered oversight, and monitoring activities and contribute to continuous improvement of the compliance program.
• Identify opportunities to simplify, modernize, and continuously improve compliance processes, tools, and governance to better support evolving business needs.
• Partner effectively across Global Functions, Legal, Finance, Business Development and cross-functional stakeholders to advance strategic priorities while promoting compliant and ethical business practices.
• Influence stakeholders through credibility, collaboration, and thoughtful challenge to promote compliant, ethical, and commercially informed business practices.
• Contribute to a culture of accountability, integrity, and ethical decision-making, including through coaching, training, reinforcement of compliance expectations and speak-up culture.

Senior Manager, Health Care Compliance Officer – Global Functions

• Develop and lead Global and US Regulatory activities for a Development Team (s).
• Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans.
• Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed.
• Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders.
• Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources.
• Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies.
• Provide strategic regulatory input to key development documents and study reports.
• Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally.
• Formulate US regulatory strategy and filings.
• Approval of regulatory documents.
• Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines.

Director, Regulatory Strategist

• Coordinate the preparation, submission, management and maintenance of global regulatory submissions
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation
• Leads and tracks queries and commitments with regulatory agencies
• Collaborates with subject matter experts to provide written responses to queries
• Provides periodic status updates regarding conditions/commitments
• Provides representation for study-level regulatory activities
• Participates in cross-functional departmental team projects and product development activities/meetings

Manager, Regulatory Affairs Strategy – Oncology

• Compliance program leadership. Under the direction of the GC/Compliance Officer, lead day-to-day execution and continuous improvement of Cosette’s enterprise compliance program, including the Code of Conduct, Compliance Policy, MLR SOP, HCP Interactions SOP, Drug Price Transparency Reporting Policy, AI Usage Policy, and related SOPs.
• Compliance Committee. Support the GC/Compliance Officer in convening the Compliance Committee — develop the agenda, document deliberations, and prepare reports to the CEO and the Audit Committee on program effectiveness, risks identified, and remediation status at the cadence directed by the GC/CO.
• Policy development and maintenance. Own a documented policy lifecycle (version control, periodic review cadence, named owners, change log) and ensure consistent defined terms and cross-references across the policy suite.
• Risk assessment, auditing, and monitoring. Conduct an annual enterprise compliance risk assessment; build and execute a risk-based monitoring and auditing workplan; document findings, corrective actions, and effectiveness verification.
• HCP interactions and fraud-and-abuse compliance. Oversee compliance with the Federal Anti-Kickback Statute, False Claims Act, and applicable OIG guidance (including the 2020 Special Fraud Alert on speaker programs) governing interactions with healthcare professionals.

Director, Compliance

• Ensuring compliance with regulatory requirements for promotional and non-promotional materials
• Leading discussions for assigned products during the Promotional Material Review Team (PMRT)
• Supporting interactions with regulatory authorities
• Preparing regulatory submissions for promotional materials
• Developing and delivering training programs on promotional regulations
• Monitoring enforcement actions and industry trends

Associate Director, Global Regulatory Advertising and Promotion

• Draft cover letters and support the preparation of various applications (ie: IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions.
• For CTA/INDs – Ensure protocols are in alignment with regulatory requirements and provide advice on required documents and submission strategies in preparation for those filings.
• For Marketing Authorization Applications (NDA, MAA or other major HA submissions): Provide regulatory support throughout the registration process.
• Advise team on required documents and submission strategies in preparation of NDA, MAA (and other global filings) as assigned (in collaboration with LOCs as appropriate).
• Assist with timely NDA, MAA (other) availability, ensure that all document components are in place on time, identify and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other).
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.
• Assist in the preparation of meetings with Regulatory Agencies.
• Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses.
• May include other activities as delegated by the RRL/GRL.
• Liaise with LOCs, track dates of submissions/responses to queries in a timely manner.
• Acts as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed.
• May be responsible for organizing and leading meetings.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Supports GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate.
• Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs).
• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.
• Partner with regulatory colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease area-specific issues.
• May assist in the development and improvement of regulatory processes.

Manager, Global Regulatory Scientist – Regulatory Affairs

• Develop and lead Casepoint’s enterprise Governance & Compliance strategy, ensuring scalable governance practices that support business growth and customer trust.
• Own enterprise privacy, compliance, AI governance, information governance, and corporate policy programs.
• Establish governance frameworks for emerging technologies, including responsible AI, data governance, and regulatory compliance.
• Partner with Executive Leadership to proactively identify, assess, and manage regulatory, contractual, operational, and technology-related risks.
• Provide executive oversight of the contracts function by partnering with the Director of Government Contracts on strategy, governance, risk management, and operational priorities.
• Collaborate with Sales, Product, Finance, Security, Legal, Engineering, and Customer Success to enable growth while balancing business objectives with appropriate governance.
• Develop executive reporting, governance metrics, and compliance dashboards to support informed decision-making.
• Drive continuous improvement through scalable processes, automation, and technology-enabled governance solutions.
• Monitor evolving regulatory requirements and industry best practices, recommending proactive enhancements to governance programs.

VP, Governance and Compliance

• Works as an audit subject matter expert and may coach and educate others
• Oversees and/or independently performs audits from end-to-end
• Conducts audit work based on established audit plans and executes the audit in accordance with established standards
• Presents objective and independent audit opinion on the adequacy of internal controls

Audit Compliance Manager

• Proactively monitor, synthesize, and prioritize global enforcement signals and inspection outcomes (e.g., inspection observations, recalls, and warning letters) to produce predictive insights and identify emerging inspectorate focus areas.
• Develop actionable insights for site inspection readiness programs, including themes, readiness expectations, recommended mitigations, and monitoring of progress aligned to observed enforcement trends.
• Translate enforcement trends into capability-building deliverables (e.g., targeted deep-dives, inspection readiness playbooks, and training) for sector/site readiness teams and site/corporate auditors.
• Support the design and maintenance of an early-warning system that combines manual curation and automated analytics (machine learning, trend detection) to surface emerging inspectorate priorities.
• Partner with internal audit leaders to inform risk-based audit planning and refine audit focus areas based on external enforcement signals and evolving inspectorate priorities.
• Provide enterprise regulatory insights and analysis in collaboration with Enterprise Compliance, offering a comprehensive, strategic view of global compliance posture, key risks, and priority actions across the enterprise.
• Produce periodic enforcement trend reports, dashboards/briefings, and executive-ready communications for senior leaders and regulatory intelligence stakeholders.

Director, Regulatory Intelligence Enforcement

• Implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
• Represent the regions and contribute to the regional and global regulatory strategy through participation in product-related teams.
• Advise product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.
• Lead the Regional Working groups to ensure timely execution of product objectives and align regional deliverables with those of the global teams.
• Facilitate tactical implementation at the regional level and ensure ongoing and effective communications with the regional and global teams on product activities and issues.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
• Liaise directly with Local operating companies as needed and assist in the preparation for meetings with regulatory agencies in the regions.
• Oversee management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
• Development of regional marketing approval submission plans in collaboration with Regional and Global regulatory teams, including submission plans and preparation submission documents.
• Preparation of registration dossiers and dossier re-use strategies.

Manager, Regional Regulatory Affairs – Cross-Regional Operations and Strategy Support

• Responsible for all aspects of the organization’s corporate compliance program and associated fraud, waste, and abuse prevention initiatives.
• Manage the day-to-day activities of the Compliance Division.
• Develop and update written internal standards of conduct and associated policies.
• Oversee the maintenance of the organizational-wide compliance reporting process.
• Provide oversight of organizational-wide privacy including HIPAA Privacy and Breach Notification Rules compliance.
• Develop and conduct organizational-wide compliance-related training and education.
• Prepare agenda materials for compliance committees and report out.
• Develop and perform focused audit-related activities including compliance reviews and risk assessments.
• Conduct, manage, and document investigatory activities in response to compliance-related complaints.

Compliance jobs in New Jersey

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Lead Technology Compliance

Manager, Regulatory Intelligence

Lead Technology Compliance

Consultant, Environmental Health and Safety – Compliance

Associate Manager, Regulatory Advertising & Promotion

Associate Manager, Regulatory Affairs Strategy – Oncology

Director, Technology Compliance

Senior Manager, Health Care Compliance Officer – Global Functions

Senior Manager, Health Care Compliance Officer – Global Functions

Director, Regulatory Strategist

Manager, Regulatory Affairs Strategy – Oncology

Director, Compliance

Associate Director, Global Regulatory Advertising and Promotion

Manager, Global Regulatory Scientist – Regulatory Affairs

VP, Governance and Compliance

Audit Compliance Manager

Director, Regulatory Intelligence Enforcement

Director, Regulatory Intelligence Enforcement

Manager, Regional Regulatory Affairs – Cross-Regional Operations and Strategy Support

Director, Corporate Compliance