JouléNewRegulatory Affairs Senior Manager JouléRegulatory Affairs Senior ManagerWarren, NJ$73–$76 / hourThe purpose of this role is to execute OTC regulatory activities for new products registrations and life-cycle maintenance for the portfolio of products defined by the US Business Units. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Daiichi Sankyo, Inc.NewManager, Regulatory Affairs- CMC Daiichi Sankyo, Inc.Manager, Regulatory Affairs- CMCBasking Ridge, NJ$127,280–$190,920 / yearFull timeWith a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for review by higher-level manager.
JouléNewGlobal Regulatory Compliance Manager JouléGlobal Regulatory Compliance ManagerMontville, NJ$115,000–$155,000 / yearSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Conduct global risk assessments, interpret complex multi-regional requirements, and develop strategies to mitigate regulatory risks.
Company ConfidentialNewManager, Scientific Affairs Company ConfidentialManager, Scientific AffairsParsippany, NJ$100,000–$130,000 / yearFull timeDirectly and effectively partner and collaborate with DSA and DSI Supply Chain, Field Support, Training, Marketing, Quality and Legal to strengthen relationships and mutual trust. Develop, with Director of Market Access, key metrics for staff to ensure project timeliness and manage staff adherence to timelines.
Daiichi Sankyo, Inc.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.
JouléNewRegulatory Affairs Senior Associate JouléRegulatory Affairs Senior AssociateWarren, NJ$49.15–$49.15 / hour2-4 years’ experience in regulatory affairs including chemistry, manufacturing and controls, and OTC experience, preferably within a CPG/Consumer Healthcare/Pharma industry. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Clinical Dynamix, Inc.NewSenior Director, Regulatory Affairs Clinical Dynamix, Inc.Senior Director, Regulatory AffairsJersey City, NJThe Senior Director will represent Company in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department.
SOFIEQuality Manager, Partners SOFIEQuality Manager, PartnersTotowa, NJ$90,000–$100,000 / yearThe successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical Operations - 30014765 Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical Operations - 30014765Basking Ridge, NJ$133,600–$200,400 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Daiichi Sankyo, Inc.Clinical Study Manager, Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Clinical OperationsBasking Ridge, NJ$136,080–$204,120 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical OperationsBasking Ridge, NJ$133,600–$200,400 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
System OneNewHousing Case Manager (Spanish/English) System OneHousing Case Manager (Spanish/English)White Plains, NY$21–$24 / hourThis role is an excellent fit for entry-level social workers, recent graduates in social work or human services, and candidates with experience in social services, nonprofit organizations, shelters, case management, resident services, or community outreach who are looking to grow their careers in a structured, mission-driven environment. At least three (3) years of experience working with individuals and families in social services, nonprofit organizations, shelters, affordable housing, case management, or community outreach also considered in lieu of a degree .
JobotNewVice President Clinical Development Ophthalmology JobotVice President Clinical Development OphthalmologyHoboken, NJ$350,000–$400,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. 4. Collaborate with cross-functional teams including regulatory affairs, pharmacovigilance, and medical affairs to ensure a holistic approach to product development.
VNS HealthNewClinical Assessment Manager VNS HealthClinical Assessment ManagerNew York, NY$85,000–$106,300Minimum two years of clinical assessment, homecare or hospital experience requiredExcellent organizational and time management skills, interpersonal skills, verbal and written communication skills requiredDemonstrated strong relationship management skills, including a high degree of psychological sophistication and non-aggressive assertiveness requiredDemonstrated successful conflict management skills and negotiation of “win-win” solutions requiredWorking knowledge of Microsoft Excel, Power-Point, and Word requiredKnowledge of Medicaid and/or Medicare regulations requiredWorking Knowledge of UAS-NY preferred . Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan.
VNS HealthNewClinical Assessment Manager-Manhattan/Queens or Brooklyn-Bilingual Chinese Speaking Required VNS HealthClinical Assessment Manager-Manhattan/Queens or Brooklyn-Bilingual Chinese Speaking RequiredNew York, NY$85,000–$106,300Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan. We’re one of the largest nonprofit home- and community-based health care organizations in the country, and today, more than 11,500 team members work together to make a difference in the lives of more than 99,000 patients and members on any given day.
Daiichi Sankyo, Inc.Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Daiichi Sankyo, Inc.Assistant General Counsel Commercial Daiichi Sankyo, Inc.Assistant General Counsel CommercialBasking Ridge, NJ$228,160–$342,240 / yearFull timeWork in an exciting and challenging legal environment by independently providing innovative and strategic legal support and solutions as a brand attorney and the primary legal advisor for the commercial business and operations supporting U.S. approved (or to be approved) oncology products and to specific assigned business functions in the Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs, Sales, Marketing, etc.) including, but not limited to, areas of vendor agreements, legal, business and regulatory issues. 7 or More Years pharmaceutical industry experience, particularly supporting specific assigned products and business areas in contracting, general legal advice, policy development and/or review, etc. in specific business support functions in an in-house capacity, as a legal consultant, and/or at a law firm in a practice group focusing on pharmaceutical industry and/or specific corporate business functions preferred .
Clinical Dynamix, Inc.NewExecutive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJThe Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.
ImmunityBio IncRegulatory Affairs Program Manager ImmunityBio IncRegulatory Affairs Program ManagerSummit, 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.
Macpower Digital Assets Edge Private LimitedRegulatory Affairs Manager Macpower Digital Assets Edge Private LimitedRegulatory Affairs ManagerNew York, NY$43–$55 / hourSummary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs ManagerNew York, NY$90–$130 / hourThe Senior Regulatory Affairs Manager ensures regulatory compliance of The client / LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
ImmunityBio IncManager, Regulatory Lifecycle Maintenance ImmunityBio IncManager, 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.
EssenlixSenior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k) EssenlixSenior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)Monmouth Junction, New JerseyEssenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing. We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development.
LancesoftNewRegulatory Affairs Senior Manager LancesoftRegulatory Affairs Senior ManagerWarren, NJJob Purpose: The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle Maintenance for the portfolio of products defined by the US Business Units. Provides advice on US-specific activities and ways of working and processes; Proactively identify potential risks and manage impact of regulatory changes within defined scope of.
EnergyHubManager, Policy and Regulatory Affairs EnergyHubManager, Policy and Regulatory AffairsBrooklyn, NY$100,000–$125,000 / yearPrioritize the highest-leverage advocacy opportunities and initiatives related to grid modernization, integrated resource planning, demand-side management, transportation electrification, energy storage, rate cases, state and federal legislation and grant programs, etc. Work with the latest technologies: You'll gain exposure to a broad spectrum of IoT, SaaS and machine learning obstacles, including distributed fault-tolerance, device control optimization, and process modeling to support scalable interaction with disparate downstream APIs.
CEDENTQuality and Regulatory Manager CEDENTQuality and Regulatory ManagerHackensack, NJThe client is in search of a Quality and Regulatory Manager to join our growing team, responsible for the management and execution of day to day Quality and Regulatory systems. KEY RESPONSIBILITIES:Manage and execute daily QA and Regulatory activities including Change Control, Document Control, Deviations/Non-Conformances, CAPAs, Supplier Management.
TechDigital CorporationScientific - Global Regulatory CMC Manager TechDigital CorporationScientific - Global Regulatory CMC ManagerSummit, NJ2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
WD-40 COMPANYGlobal Regulatory Compliance Manager WD-40 COMPANYGlobal Regulatory Compliance ManagerPine Brook, New JerseyProvide dotted-line leadership and strategic guidance to regional regulatory leads (EMEA, Americas, Asia-Pac). As we expand our global footprint and navigate an increasingly complex regulatory landscape, we’re creating a brand-new role to lead our worldwide regulatory compliance strategy.
Bank of China Limited, New York BranchLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of China Limited, New York BranchLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearOversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. The VP establishes and maintains RAO policies/procedures and oversees all Regulatory Affairs Matters, including project management, stakeholder relationships, and day-to-day processes, communication with regulators, tracking and coordinating regulatory deliverables, driving the submission process to ensure timely execution and quality assurance, and reporting regulatory updates to Bank Management and committees.
Philip Morris International U.S.Sr. Manager, Regulatory & Compliance Reporting Philip Morris International U.S.Sr. Manager, Regulatory & Compliance ReportingStamford, CTFull time10+ years of progressive experience in regulatory reporting, excise/compliance operations, licensing, or regulatory tax operations, 5+ years of experience working in a highly regulated nicotine/tobacco environment (smokeless tobacco, modern oral nicotine pouches, heated tobacco, ENDS, or adjacent regulated consumer goods). Position Overview: The Senior Manager, Regulatory & Compliance Reporting leads U.S. federal and state tobacco/nicotine regulatory reporting and the full lifecycle of tax-related licensing and permits for a multi-entity, multi-site smoke-free and smokeless portfolio (e.g., nicotine pouches, traditional smokeless tobacco, heated tobacco).
VolgapartnersNewLanguage Data Quality Reviewer - Traditional Chinese (Entry-Level - L1) VolgapartnersLanguage Data Quality Reviewer - Traditional Chinese (Entry-Level - L1)New York, NY$3–$4 / hourImportant NotesThis role is designed for supplemental, flexible engagementNo guaranteed minimum hoursNo guaranteed end dateTasks are offered first‑come, first‑servedWhile advancement is not guaranteed, future opportunities may evolve based on project needs, performance, and budgetWhy This RoleGain hands‑on experience working on real AI and language data projectsBuild practical skills in data quality, annotation, and content reviewFlexible, remote work that fits around your scheduleOpportunity to stay engaged in ongoing and future AI programsVisibility into higher‑scope opportunities as projects expandMust be able to read and write in required language(s)Must understand this is a task‑based freelance roleMust have a reliable computer or laptopMust have stable internet connectionMust be comfortable with flexible and intermittent work#J-18808-Ljbffr. Onboarding & ComplianceGlobal contractors are onboarded through DeelU.S.-based workers are onboarded through Volga Partners' payroll systemRequired documentation must be completed prior to startingCompensationHourly compensation varies by country, language, and experience level.
Judge GroupDirector, Regulatory Affairs Strategy Judge GroupDirector, Regulatory Affairs StrategyWarren, NJ$190,000–$220,000 / yearThis individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes.
Stark Pharma Solutions IncNewRegulatory Affairs Associate Stark Pharma Solutions IncRegulatory Affairs AssociatePiscataway, NJWe are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products. Hi, My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.
Axsome TherapeuticsAssociate Director/Director, Regulatory Affairs Axsome TherapeuticsAssociate Director/Director, Regulatory AffairsNew York City, NYRemote$160,000–$215,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members.
ImmunityBio IncSenior Scientist, Regulatory CMC ImmunityBio IncSenior Scientist, Regulatory CMCSummit, 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. This position will support the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc.
Vera TherapeuticsNewVice President, Regulatory Affairs Vera TherapeuticsVice President, Regulatory AffairsNew York, NY$259,000–$394,000 / yearVera Therapeutics' lead product candidate is atacicept, a fusion protein self‑administered at home as a subcutaneous once weekly injection that blocks both B‑cell Activating Factor (BAFF) and A Proliferation‑Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre‑submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
Lupin LtdSenior Director, Regulatory Affairs Lupin LtdSenior Director, Regulatory AffairsSomerset, NJThe Senior Director of Regulatory Affairs is responsible for establishing regulatory direction and providing management support for the US development of complex Inhalation products within Lupins complex portfolio, with a robust execution skill set. This role should also have the capability to implement 505b (2) strategies and submissions, a strong communication strategy with the FDA, and additional strong expertise in the Medical Device area, and the ability to understand the PK/PD strategy.
Kleinfelder, Inc.Entry Level Civil Engineer Kleinfelder, Inc.Entry Level Civil EngineerLinden, NJFull timeOur collaborative, multidisciplinary group spanning architectural, structural, civil, electrical, mechanical, process engineering, pipeline design, and integrity management works together to deliver integrated, high‑impact solutions. 1-4 years of relative experience or willingness to learn site/civil design including site grading, stormwater analysis, erosion/sediment control measures and earthworks estimation.
BeOne Medicines LtdSenior Director Regulatory Affairs, CMC BeOne Medicines LtdSenior Director Regulatory Affairs, CMCNY$204,500–$274,500 / yearProvide strategic and operational leadership for the development and execution of global biologics Regulatory CMC strategies for the responsible regions, including oversight of authoring, review, and lifecycle management of CMC sections of CTDs (Modules 2 and 3) for INDs, BLAs, MAAs, and post approval submissions. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
ImmunityBio IncAssociate Director, Regulatory CMC ImmunityBio IncAssociate Director, Regulatory CMCSummit, 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. The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format.
Eikon Therapeutics IncNewDirector, Regulatory Affairs Eikon Therapeutics IncDirector, Regulatory AffairsJersey City, NJ$213,000–$232,750 / yearThis role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Tris Pharma IncSpecialist, 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.
JPMorgan Chase Bank, N.A.Associate, Regulatory Affairs - Global Government Relations JPMorgan Chase Bank, N.A.Associate, Regulatory Affairs - Global Government RelationsNew York, NYFull timeAs the public policy environment globally is evolving rapidly due to technological change and a desire by policymakers to drive economic growth and international competitiveness, you will provide support to the CIB Regulatory Affairs team in responding to this dynamic environment and feed into the firm's advocacy, engagement, and strategic responses on key regulatory policy issues. 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.
IntelliPro Group Inc.Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJThis role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.
Oscar HealthSenior Analyst, Regulatory Affairs Oscar HealthSenior Analyst, Regulatory AffairsNew York City, NYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Dennis PartnersNewVP or SVP of Regulatory, Quality & Medical Writing Dennis PartnersVP or SVP of Regulatory, Quality & Medical WritingNew York, NYRemote$375,000–$425,000 / yearIn close partnership with the Head of QA, oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks. Must have strong ex-US Regulatory experience, preferably with EU/EMA and MHRA.Demonstrated understanding of drug development and the integration of activities required to achieve goals.
Mizuho Americas Services LLCRegulatory Change Management Mizuho Americas Services LLCRegulatory Change ManagementNew York, NYFull timeThe group is responsible for managing regulatory examinations, reviews, continuous monitoring, inquiries, horizon scanning for emerging regulations, regulatory change management, maintenance of the laws, rules and regulations library, firmwide regulatory projects and other regulatory-related matters. The Regulatory Affairs Group is seeking a Vice President of Regulatory Change Management who will lead the horizon scanning process to identify upcoming regulatory changes, analyze requirements to determine downstream implications and communicate assessments to impacted stakeholders.
The Hain Celestial Group IncSr. Associate Regulatory Affairs The Hain Celestial Group IncSr. Associate Regulatory AffairsHoboken, NJRemoteRole Purpose The Senior Associate Regulatory Affairs is responsible for ensuring that all products labels and marketing claims comply with applicable regulatory requirements across domestic and international markets. This role supports product innovation and commercialization by providing regulatory guidance, managing submissions, and partnering cross-functionally to mitigate compliance risk while enabling speed to market.
ImmunityBio IncRegulatory 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.