Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
Manager, Regulatory Affairs- CMC Daiichi Sankyo, Inc.Manager, Regulatory Affairs- CMCBasking Ridge, NJ$127,280–$190,920 / yearFull timep style="margin:0in;line-height:normal;font-size:12pt;font-family:'aptos' , sans-serif">Download Our Benefits Summary PDF. Responsibilities.
NewRegulatory Affairs Senior Associate electroCore IncRegulatory Affairs Senior AssociateRockaway, NJThe position provides regulatory strategy input, prepares and maintains submission and technical documentation content, evaluates product and labeling changes, supports post-market and vigilance obligations, and partners cross-functionally to ensure compliant, timely execution of business objectives. • Provide practical regulatory strategy input for new products, product modifications, labeling changes, software/app updates, manufacturing changes, supplier changes, and market expansion activities.
Associate Director, Regulatory (RIM) Business Systems and Operations Daiichi Sankyo, Inc.Associate Director, Regulatory (RIM) Business Systems and OperationsBasking Ridge, NJ$157,920–$236,880 / yearFull timep style="margin:0in;line-height:normal;font-size:12pt;font-family:'aptos' , sans-serif">Download Our Benefits Summary PDF. The Associate Director, Business Systems & Operations Management will function at various times as a manager of one or more business systems, as a leader of sub-teams or workstreams within larger projects or programs, as a contributor within various systems-related working groups, and as a senior business analyst, as required.
MDS Specialist RN Care-OneMDS Specialist RNWhippany, NJ$83,000–$120,000 / yearUtilization Review & Triple-Check Coordination: Lead the weekly Utilization Review (UR) and Triple-Check meetings, collaborating with therapy, nursing, and the business office to validate medical necessity, track managed care authorizations, and ensure accurate billing alignment prior to transmission. Lead MDS/Clinical Reimbursement Coordinator will be responsible for, but not limited to: MDS/RAI Process Leadership: Direct the timely and accurate completion of the Minimum Data Set (MDS) and Care Area Assessments (CAAs) in strict compliance with CMS regulations.
Quality Assurance Specialist (QAS) I SOFIEQuality Assurance Specialist (QAS) ITotowa, NJ$70,000–$75,000 / yearEnsure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
BUS ANAL - Senior Specialist AI & Data Solutions ECLAROBUS ANAL - Senior Specialist AI & Data SolutionsLawrence Township, NJ$58.78–$62.34 / hourstrong>Position Overview:This role serves as the Web Delivery Lead within the Global Digital Engagement Platforms team, responsible for leading the end-to-end delivery of enterprise websites built on the Adobe Experience Manager (AEM) platform. Responsibilities:Delivery Leadership & Governance:Lead end-to-end delivery of AEM-based websites across global markets, managing timelines, risks, and stakeholder expectations.
NewDigital Marketing Specialist ECLARODigital Marketing SpecialistLawrence Township, NJ$81.74–$86.69 / hourstrong>Position Overview:The Omnichannel Strategist serves as a dedicated point-of-contact for a brand, their creative, digital and media agencies, ensuring seamless planning and execution of omni-channel campaigns / tactics aligned to the brand strategy. If needed, lead internal MLR review processes and work with external partners to ensure timely and accurate preparation of digital programs (e.g., CRM, third-party programs, HCP media, websites, mobile, email, social media, SEO / SEM, IVA, Field-Trigger e-mails, etc.).
Digital Operations - Digital Marketing Specialist ECLARODigital Operations - Digital Marketing SpecialistLawrence Township, NJ$69.48–$73.69 / hourstrong>Responsibilities: Strategic Financial Management:Direct and manage production budgets across a portfolio of brands or therapeutic areas, ensuring prudent allocation of resources aligned with strategic priorities. Position Overview:The US Content Production Manager serves as a pivotal strategic and operational partner within a highly matrixed organizational framework, working in close alignment with Brand and Omnichannel Strategy teams.
NewD06 - PROJECT MANAGEMENT / PROJECT MGMT - Specialist, Scheduling and Cell Logistics ECLAROD06 - PROJECT MANAGEMENT / PROJECT MGMT - Specialist, Scheduling and Cell LogisticsMadison, NJ$34.69–$36.79 / hourPosition Overview:The Site Account Specialist, Scheduling and Cell Logistics will be responsible for scheduling and monitoring patient treatment schedules for the manufacturing of the company's commercial autologous cellular immunotherapy products. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world.
Pharmacovigilance (PV) Analytics and Reporting Specialist ECLAROPharmacovigilance (PV) Analytics and Reporting SpecialistLawrenceville, NJstrong>Responsibilities:Data Analytics and ReportingBuild and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making. The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across PS.
Banking Operations Specialist CollaberaBanking Operations SpecialistWhippany$30–$35 / hourTemporaryContractorStrong analytical skills with the ability to synthesize large volumes of data and identify meaningful patterns. Excellent written and verbal communication skills, with experience preparing investigative reports.
Legal Collections Specialist (Paralegal) Page GroupLegal Collections Specialist (Paralegal)Maywood, NJ$75,000–$90,000 / yearFull timeThe Legal Collections Specialist (Paralegal) plays a pivotal role in driving revenue recovery and protecting the company's financial health by overseeing accounts receivable and leading strategic collections efforts. This is an exciting opportunity to make a direct impact within a growing, fast-paced business services organization in Maywood, where your expertise will help shape effective processes and ensure compliance at every stage.
NewExecutive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Download Our Benefits Summary PDF.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timep style="margin:0in;line-height:normal;font-size:12pt;font-family:'aptos' , sans-serif">Download Our Benefits Summary PDF. As a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs.
Engineering - Automation Specialist EclaroEngineering - Automation SpecialistWarren, NJ$61.02–$64.72 / hourFull timeResponsibilities:Develop, and qualify automated methods for Cell therapy QC assays (e.g., flow cytometry, cell-based assays, molecular-based assays, and cell viability) using automated liquid handlers and integrated platforms. This hands-on role will focus on designing, programming, and optimizing automation scripts and workflows for platforms such as Hamilton and Tecan, ensuring seamless technical transfer and compliance within a GMP environment.
Specialist, Regulatory Affairs Advertising & Promotion Review Tris Pharma IncSpecialist, Regulatory Affairs Advertising & Promotion ReviewMonmouth Junction, NJ$100,000–$140,000 / yearLeads regulatory reviews of external communications intended for healthcare professionals (HCPs), patients and caregivers, ensuring high-quality, accurate and compliant content aligned with US laws, Food and Drug Administration (FDA) regulations and guidance, Pharmaceutical Research and Manufacturers of America (PhRMA) principles and company policies. Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs.
Staff Specialist, Regulatory Affairs StrykerStaff Specialist, Regulatory AffairsMahwah, New JerseyRemoteHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Work Flexibility: Remote or Hybrid or OnsiteStryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and instrument portfolio across U.S and international markets.
Senior Specialist, Regulatory Affairs ImmunityBio IncSenior Specialist, Regulatory AffairsSummit, NJp>ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Regulatory Affairs Specialist, Digitalization Becton Dickinson and CoRegulatory Affairs Specialist, DigitalizationFranklin Lakes, NJ$110,200–$176,400 / yearProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Knowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
Regulatory Specialist L'Air Liquide SARegulatory SpecialistNJ$90,000–$100,000 / yearOperating at the intersection of regulatory affairs and client relations, this role is critical to managing global documentation requests, ensuring adherence to FDA guidelines, and collaborating closely with internal stakeholders and external manufacturing principals. The Regulatory Department at Seppic Inc. acts as a crucial link between scientific compliance and global market access, safeguarding portfolios while supporting commercial teams.
Specialist, Regulatory Affairs Operations Publishing Taiho OncologySpecialist, Regulatory Affairs Operations PublishingPrinceton, NJ$86,700–$102,000 / yearFull timeThe Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data and maintains compliance with evolving regulations and technologies—including AI—to support drug review, approval and market access while protecting public health. Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis’ CARA), and the ability to learn required systems and processes quickly.
Regulatory Affairs Specialist Actalent IncRegulatory Affairs SpecialistMahwah, NJ$28–$33 / hourCoordinate, prepare, and review regulatory documents and certifications for example: Specifications, Safety Data Sheets (SDS), Flavor/Fragrance Allergens, BE/GMO, Organic, Natural, IFRA, Country of Origin, GRAS, Kosher, Nutritional. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Senior International Regulatory Affairs Specialist Becton Dickinson and CoSenior International Regulatory Affairs SpecialistFranklin Lakes, NJ$110,200–$176,400 / yearFor most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Regulatory Affairs Specialist Terumo Medical CorpRegulatory Affairs SpecialistSomerset, NJ$61,440–$84,480 / yearTerumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.
Regulatory Affairs Specialist Hybrid Spectrum VascularRegulatory Affairs Specialist HybridBridgewater, NJThis role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics.
Regulatory Transformation Specialist - Field Action Integra LifeSciences Holdings CorpRegulatory Transformation Specialist - Field ActionPrinceton, NJ$71,300–$97,750 / yearSupport the execution and tracking of global regulatory field action activities, including monitoring regulatory requirements, maintaining country-specific timelines, and ensuring required documentation (e.g., notifications, effectiveness checks, closure records) is complete, accurate, and inspection-ready. Support enterprise regulatory transformation team initiatives with a primary focus on Field Actions, including recalls, corrections and removals, FSN/FSCA activities, and other postmarket regulatory obligations, while supporting additional transformation priorities as needed.
Regulatory Specialist Actalent IncRegulatory SpecialistPARSIPPANY TROY HILLS, NJ$30–$35 / hourParticipate in the regulatory review, preparation, and submission of clinical study documentation such as investigator brochures, Investigational Device Exemptions (IDE), Investigational New Drug (IND) applications, and treatment or compassionate/emergent use documents. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Regulatory Specialist Hackensack University Medical CenterRegulatory SpecialistHackensack, NJThe Regulatory Specialist will serve as liaison to investigators, collaborating divisions, departments and institutions, the Institutional Review Board (IRB) and external regulatory agencies. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed.
Regulatory Specialist SPECTRUM LABORATORY PRODUCTS, INC.Regulatory SpecialistNew Brunswick, NJCorp., a division of Spectrum Laboratory Products, Inc., has grown into the chemical industry's leading customer-focused global supplier of high quality chemicals, laboratory supplies and equipment. The California and New Jersey plants are also FDA registered drug establishments and operate under current Good Manufacturing Practices (cGMP).
Regulatory Operations Documentation Specialist JouléRegulatory Operations Documentation SpecialistFlorham Park, NJRemote$31–$54 / hourThe scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
NewFinancial Crime Risk Specialist - Regulatory Response & Audit Oversight The Toronto-Dominion BankFinancial Crime Risk Specialist - Regulatory Response & Audit OversightMount Laurel, NJ$91,000–$145,600 / yearTotal Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Employee/Team Accountabilities: Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and ensure timely communication of issues / points of interest.
Regulatory Documentation Specialist III ImmunityBio IncRegulatory Documentation Specialist IIISummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Specialist II, Regulatory Lifecycle Maintenance ImmunityBio IncSpecialist II, Regulatory Lifecycle MaintenanceSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
PCI Assessment Specialist, Global Regulatory Assessments JPMorgan Chase & CoPCI Assessment Specialist, Global Regulatory AssessmentsJersey City, NJAs a PCI Specialist at JPMorganChase in the Cybersecurity Technology and Controls Global Regulatory Assessments team, you will oversee end-to-end PCI assessment processes, serving as the firm''s subject matter expert on PCI DSS frameworks. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.
Specialist III, Regulatory Lifecycle Maintenance ImmunityBio IncSpecialist III, Regulatory Lifecycle MaintenanceSummit, NJBachelor's degree in life sciences or a related field required; 5+ years of relevant regulatory clinical Science experience is required, or • Master's degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required • Experience in the preparation of the submission of clinical modules in eCTD format is preferred • Familiar with organizing responses to Health Authority information requests is preferred • Familiarization with regulatory submissions internationally is preferred. ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
Regulatory Documentation Specialist II ImmunityBio IncRegulatory Documentation Specialist IISummit, NJFormat and compile documents according to requirements specified by Regulatory Agencies Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements Prepare document shells for inclusion of text and data Assist in training Regulatory Documentation Specialists ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Bachelor's Degree in life sciences or technical discipline with 2+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or High school diploma with 6+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required.
Regulatory Compliance Specialist (On-Site) Evolution ABRegulatory Compliance Specialist (On-Site)Atlantic City, NJ$65,000–$75,000 / yearOur live services, which allow licensees' players on desktop, tablet and smartphone to play Live Casino games at real tables and with real dealers, have won multiple industry awards, including 'Live Casino Supplier of the Year' at the EGR B2B Awards for eleven consecutive years and 'Casino Content Provider of the Year' in the 2019 EGR North America Awards. Evolution is the world´s leading provider of video-streamed Live Casino solutions and Slots, delivering best-in-class 'as real as it gets' live dealer gaming to our licensees including many of the world´s best known gaming brands.
Regulatory Compliance Specialist Evolution ABRegulatory Compliance SpecialistAtlantic City, NJ$65,000–$75,000 / yearp>Our live services, which allow licensees' players on desktop, tablet and smartphone to play Live Casino games at real tables and with real dealers, have won multiple industry awards, including 'Live Casino Supplier of the Year' at the EGR B2B Awards for eleven consecutive years and 'Casino Content Provider of the Year' in the 2019 EGR North America Awards. Evolution is the world´s leading provider of video-streamed Live Casino solutions and Slots, delivering best-in-class 'as real as it gets' live dealer gaming to our licensees including many of the world´s best known gaming brands.
Quality/Regulatory - Senior Specialist, Environmental, Health and Safety {Mahwah, NJ} Matlen Silver, Inc.Quality/Regulatory - Senior Specialist, Environmental, Health and Safety {Mahwah, NJ}Mahwah, NJThis role serves as a subject matter expert and key contributor to the site's EH&S strategy, supporting and mentoring the organization to ensure effective implementation of EH&S processes aligned with business needs. Additional certifications such as First Aid, CPR, Hazardous Materials Technician, Incident Command, and respirator clearance are a plus.
NewFinancial Crime Risk Specialist - Regulatory Response & Audit Oversight TD BankFinancial Crime Risk Specialist - Regulatory Response & Audit OversightMount Laurel, New JerseyTotal Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and ensure timely communication of issues / points of interest.
AVP, Senior Regulatory & Governance Risk Management Specialist Everest GroupAVP, Senior Regulatory & Governance Risk Management SpecialistWarren, New JerseyThe role acts as a senior subject matter expert on regulatory risk governance, supporting engagement with regulators and internal stakeholders, and contributing to the ongoing development and embedding of the Enterprise Risk Management (ERM) framework with a focus on non-financial risks. We are a global team focused on disciplined capital allocation and long-term value creation for all stakeholders, who care deeply about our impact on communities and the wider world.
Regulatory Compliance Specialist J&J Snack FoodsRegulatory Compliance SpecialistMount Laurel, New JerseyAs a leader and innovator in the snack food industry for over 50 years, J&J Snack Foods provides branded snack foods to foodservice and retail supermarket outlets across the U.S. Its products include such icons as SUPERPRETZEL, ICEE, and Dippin’ Dots along with other key brands like LUIGI’S Real Italian Ice, The Funnel Cake Factory Funnel Cakes, and Hola Churros. ESSENTIAL FUNCTIONS: Verifies label content and provides approval on all finished product labels by applying a thorough knowledge of federal, state, local, and international food labeling requirements.
PCI Assessment Specialist, Global Regulatory Assessments JPMorgan Chase Bank, N.A.PCI Assessment Specialist, Global Regulatory AssessmentsJersey City, NJFull timeAs a PCI Specialist at JPMorganChase in the Cybersecurity Technology and Controls Global Regulatory Assessments team, you will oversee end-to-end PCI assessment processes, serving as the firm's subject matter expert on PCI DSS frameworks. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.
Regulatory Compliance Specialist (Americas) WD-40 CompanyRegulatory Compliance Specialist (Americas)NJYou''ll be a trusted internal advisor, a liaison with regulatory agencies, and a key partner to commercial teams navigating complex, sometimes ambiguous jurisdictional landscapes. Packaging & labeling compliance - monitoring and applying regulatory changes to artwork and labels before market deadlines hit.
Quality/Regulatory - Senior Specialist Apidel TechnologiesQuality/Regulatory - Senior SpecialistMahwah, NJContractorKey Responsibilities include maintaining the EH&S management system in accordance with internal and regulatory requirements; preparing and delivering EH&S training programs; conducting inspections and audits; preparing EH&S reports and metrics; leading the Emergency Response program; overseeing incident investigations and trend analysis; assessing EH&S impacts of proposed changes; ensuring effective risk assessment and risk reduction programs; monitoring regulatory compliance; managing waste and environmental monitoring programs; leading site EH&S projects; collaborating with site leadership; and promoting a strong culture of safety and environmental accountability. This role serves as a subject matter expert and key contributor to the sites EH&S strategy, supporting and mentoring the organization to ensure effective implementation of EH&S processes aligned with business needs.
Regulatory Operations Documentation Specialist Shionogi Inc.Regulatory Operations Documentation SpecialistFlorham Park, New Jersey$40–$57 / hourThe scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
Regulatory Operations Documentation Specialist Shionogi & Co LtdRegulatory Operations Documentation SpecialistFlorham Park, NJ$40–$57 / hourThe scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
AVP, Senior Regulatory & Governance Risk Management Specialist Everest Group LtdAVP, Senior Regulatory & Governance Risk Management SpecialistWarren, NJ$175,000–$215,000 / yearThe role acts as a senior subject matter expert on regulatory risk governance, supporting engagement with regulators and internal stakeholders, and contributing to the ongoing development and embedding of the Enterprise Risk Management (ERM) framework with a focus on non-financial risks. We are a global team focused on disciplined capital allocation and long-term value creation for all stakeholders, who care deeply about our impact on communities and the wider world.
Regulatory Affairs Strategist, Digitalization Becton Dickinson and CoRegulatory Affairs Strategist, DigitalizationFranklin Lakes, NJ$137,500–$220,100 / yearProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Knowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.