Regulatory 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.
Director, Regulatory Affairs Recursion PharmaceuticalsDirector, Regulatory AffairsNew York, NYRemote$228,250–$280,720 / yearCreate and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting.
Sr. Staff Regulatory Affairs Specialist VB Spine LLCSr. Staff Regulatory Affairs SpecialistAllendale, NJ$135,000–$145,000 / yearAs a Principal Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll apply broad and advanced knowledge of regulatory frameworks, requirements, and processes to advise cross-functional teams and leadership on complex projects and strategies - supporting global product development, lifecycle management, and regulatory. At VB Spine, join a high-performing Regulatory Affairs team where you'll provide senior-level strategic guidance that enables the successful global launch and continued compliance of innovative spinal technologies.
Regulatory Affairs Program Manager ImmunityBioRegulatory 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.
Vice President Regulatory Affairs - Cluster Perrigo Company CorporateVice President Regulatory Affairs - ClusterMorristown, NJAs VP, you will define the operating model, decision rights, governance and escalation pathways needed to connect Category Regulatory Affairs, Cluster Regulatory Affairs, Lifecycle Management, Regulatory Operations, Quality, Safety, Supply, R&D and Commercial teams into one execution-focused regulatory voice. In this role you will lead the Global Cluster Regulatory organisation and provide senior leadership for in-market regulatory strategy, execution, registration delivery, launch readiness, lifecycle transition and ongoing market support.
Senior Managing Counsel, Regulatory Affairs Mastercard IncSenior Managing Counsel, Regulatory AffairsNew York City, NY$250,000–$400,000 / yearAll activities involving access to Mastercard assets, information, and networks comes with an inherent risk to the organization and, therefore, it is expected that every person working for, or on behalf of, Mastercard is responsible for information security and must: Abide by Mastercard's security policies and practices; Ensure the confidentiality and integrity of the information being accessed; Report any suspected information security violation or breach, and. The Global Regulatory team is looking for a Senior Managing Counsel, Regulatory to lead the MTS Regulatory team and drive the regulatory compliance program for MTS's global portfolio of money transmission/payment services licenses.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaNJ$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Staff Engineer, Packaging - Wayne, NJ Getinge ABStaff Engineer, Packaging - Wayne, NJWayne, NJWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. Develop and approve validation strategies and protocols including: IQ, OQ, PQ, Process validation, Packaging validation, Package integrity testing, Transportation simulation testing, Accelerated and real-time aging studies, and Labeling system validation.
Quality Engineer VB Spine LLCQuality EngineerAllendale, NJ$80,000–$95,000 / yearAt VB Spine, join a high-performing team, benefit from peer and executive mentorship, and play a meaningful role in ensuring the quality and safety of innovative spinal devices that improve patient lives. We're the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care.
General Counsel AccreteGeneral CounselNew York, NY$260,000–$325,000 / yearWith strategic thinking and a problem-solving mindset, you make informed decisions leveraging data and expertise, always looking for ways to improve processes, optimize workflows, and enhance outcomes beyond your immediate responsibilities. About Role : Accrete AI is seeking a strategic and experienced General Counsel to lead the company's legal function and provide counsel across all business areas, including corporate governance, contracts, intellectual property, and HR matters.
Regulatory Affairs Manager Actalent IncRegulatory Affairs ManagerNJ$90,000–$115,000 / yearOversee the preparation, review, and maintenance of regulatory documents, including TDS, SDS, allergen and GMO statements, nutritional and natural certifications, Non-GMO Project forms, Kosher and Halal certifications, certificates of origin (COO), Prop 65 documentation, flavor labeling, TTB submissions, and related materials. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Senior Manager, Regulatory Affairs - OTC Haleon Plc.Senior Manager, Regulatory Affairs - OTCWarren, NJ$152,620–$209,852 / yearThis role requires building strong relationships with internal and external stakeholders; strategic regulatory decision-making and execution of more complex projects; leadership of cross funtional team and Health Authority interactions, and developing regulatory talent (with or without formal line management responsibilities). Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment.
Director, Regulatory Affairs American International GroupDirector, Regulatory AffairsJersey City, NJThe base salary range for this position in New York, NY is $175,000-190,000, and in New Jersey the range is $170,000-`185,000 the role is eligible for a bonus in accordance with the terms of the applicable incentive plan. o Identify and escalate key themes, potential risks and mitigation plans/strategy to proactively address key perceived risks before they become issues.
Medical Science Liaison - Eastern Region PepsiCo IncMedical Science Liaison - Eastern RegionNew York, NY$123,500–$206,750 / year9+ years industry experience required in Pharmaceutical, Medical Devices, CPG, Nutrition, or related industry At least 5 years experience in a Medical Science Liaison (or parallel) position required Experience in Medical Affairs, scientific engagement, clinical education, or research‑facing roles. In addition to salary, PepsiCo offers a comprehensive benefits package to support our employees and their families, subject to elections and eligibility: Medical, Dental, Vision, Disability, Health, and Dependent Care Reimbursement Accounts, Employee Assistance Program (EAP), Insurance (Accident, Group Legal, Life), Defined Contribution Retirement Plan.
Director, US Regulatory Affairs AltimmuneDirector, US Regulatory AffairsMorristown, NJFull timePrior experience reviewing and submitting advertising and promotional materials for drugs and biological products is preferredExcellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneouslyMust be self-motivated with a positive attitude and the ability to work well with othersExcellent oral and written communication skills. D., MD, PharmD with at least 6 years of regulatory experienceOperational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agenciesThorough knowledge of FDA regulations and global regulatory guidelines governing clinical development, clinical trial applications, marketing, and post-approval application submissions.
Vice President Of Quality, Accreditation And Patient Safety Hospital for Special SurgeryVice President Of Quality, Accreditation And Patient SafetyNew York, NY$352,100–$388,025 / yearThis role integrates enterprise quality, patient safety, accreditation, medical staff quality, value- based care, infection prevention and occupational health and safety into an operational model that drives an innovative experience and cohesive delivery in the coordination of care to ensure excellence in patient experience and patient outcomes, workforce sustainability and wellbeing, financial performance, and enterprise alignment. The Vice President (VP) of Quality, Accreditation and Patient Safety serves as a senior executive leader responsible for the oversight of the quality and safety programs for HSS Enterprise including the development, strategy and execution of patient safety and quality initiatives that support the mission and vision of HSS.
Project Manager - Healthmark QMS, Defined Term (Remote in EST) Getinge ABProject Manager - Healthmark QMS, Defined Term (Remote in EST)New York City, NYRemote$120,160–$150,000 / yearRequired Knowledge, Skills and Abilities: Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones.
Sr. Quality System Data Specialist Getinge ABSr. Quality System Data SpecialistWayne, NJRemoteThe Senior Specialist will work closely with Legal Manufacturers, Quality, Regulatory Affairs, Medical Safety, Service, Manufacturing, and Information Technology teams to develop methods and tools to identify trends, detect emerging signals, automate manual processes, and provide actionable insights that support data-driven decision making. With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.
CMC Director, Regulatory Affairs AltimmuneCMC Director, Regulatory AffairsMorristown, NJFull timeEssential Functions:Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applicationsManages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goalsResponsible for the preparation of all CMC sections/information filed in support of global clinical trial and marketing applications; ensures all CMC regulatory filings are prepared accurately and completed in a timely manner Manages global CMC regulatory projects as assigned and assists in the development of relevant timelines and ensures execution to meet corporate goalsPerforms regulatory assessments of CMC changes, identifying global regulatory filing requirementsResponsible for submission of supporting amendments and updates to relevant applications for CMC-related changes Manages the preparation and submission of formal CMC-related regulatory meeting requests and briefing packages and coordinates meetings with regulatory agenciesLeads CMC-related FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's development programsInterprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligenceRepresents and participates in project/program teams and sub-teams, as requiredParticipates in the development, review, and implementation of departmental SOPs and processes. D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma industryExperience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC modules of eCTD submissionsOperational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agenciesAbility to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing CMC filing requirements for approval of marketing and clinical trial applications for drugs and biological productsExcellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneouslyExperience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs)Must be self-motivated with a positive attitude and ability to work well with othersExcellent oral and written communication skills.
Continuous Improvement Manager Mirion Technologies Inc.Continuous Improvement ManagerFlorham Park, NJThis role champions Lean, Six Sigma, and problem‑solving methodologies to improve product quality, reduce waste, enhance cost efficiency, and ensure regulatory compliance. The Continuous Improvement Manager is responsible for leading, developing, and executing strategies to drive operational excellence across the medical device manufacturing organization.