Sr Director Of Regulatory Affairs - North America Perrigo Company CorporateSr Director Of Regulatory Affairs - North AmericaMorristown, NJ$225,000–$275,000 / yearLCM & Regulatory Operations owns regulatory classification governance, post-launch lifecycle activities (non-innovation), and operational processes and systems; this role sets market priorities and delivery expectations. Category Regulatory Affairs owns ideation-to-launch strategy, regulatory pathways, and global dossier expectations; this role provides market input and executes the agreed strategy locally.
Senior Regulatory Affairs Specialist Varian Medical Systems IncSenior Regulatory Affairs SpecialistNYRemote$117,770–$161,931 / yearIt is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". As a Senior Regulatory Affairs Specialist, you will be responsible to: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
Executive Director, Regulatory Affairs - Global Regulatory Leader Summit Therapeutics IncExecutive Director, Regulatory Affairs - Global Regulatory LeaderNY$231,000–$285,000 / yearOverview of Role: The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
Analyst, Regulatory Affairs Oscar HealthAnalyst, Regulatory AffairsNew York, NY$31.45–$41.28 / hourYou will support the Regulatory Affairs Evidence of Coverage team by serving as a resource on Oscar processes and identify risks to escalate in partnership with their manager. Responsibilities: Support annual QHP filings by ensuring the quality and timeliness of annual filing inputs through initial submission and regulator facing negotiation periods.
Senior Associate, Regulatory Affairs Haleon PlcSenior Associate, Regulatory AffairsNJ$87,575–$120,415 / yearPlease 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. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees.
US Regulatory Affairs Senior Manager – Allergy ChattemUS Regulatory Affairs Senior Manager – AllergyMorristown, New JerseyOversight of labeling activities for assigned products, including creation of Drug Facts Labeling for new product launches and assessing/reviewing/approving label changes to marketed products. Provide U.S. Regulatory Affairs support for the allergy portfolio, including Allegra, Xyzal, and Nasacort, by representing Regulatory Affairs on cross-functional innovation teams, participating in advertising and promotional reviews, and supporting new product development.
Director, Regulatory Affairs Nektar TherapeuticsDirector, Regulatory AffairsNY$240,000–$275,000 / yearThis role oversees end-to-end planning and delivery of global clinical submissions, leads the creation and release of core regulatory dossiers, drives country-level customization strategies, and ensures high-quality responses to regulatory RFIs to support timely trial startup and advancement. Nektar currently anticipates the base salary for the Senior Specialist, Clinical Regulatory Affairs to range from $240,000 to $275,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience.
Medical Device Regulatory Affairs Strategist Oracle CorpMedical Device Regulatory Affairs StrategistNYRemote$87,000–$178,100 / yearAs a Principal/Lead/Senior Regulatory Affairs Specialist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). About the Role: At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry.
Senior Regulatory Affairs Program Manager ImmunityBio IncSenior Regulatory Affairs Program ManagerSummit, NJLead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes. 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 Affairs Project Manager (Piscataway, NJ, US) Colgate-Palmolive CompanyRegulatory Affairs Project Manager (Piscataway, NJ, US)Piscataway, NJ$124,000–$174,000 / yearRisk Management & Lifecycle Monitoring: Proactively identifies and monitors project risks, developing robust mitigation strategies to protect business continuity and minimize timeline impacts or regulatory penalties. Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging.
NewRegulatory Affairs Compliance Manager PBF EnergyRegulatory Affairs Compliance ManagerParsippany, NJ$106,787.51–$189,503.19 / yearThis role includes day-to-day management of ISCC program requirements and risk management, continuous monitoring of regulatory and system updates, and direct accountability for mass balance, conversion factors, GHG calculations, and audit readiness and execution. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills and internal peer equity will be considered in determining the selected candidate's compensation.
Senior Regulatory Affairs Program Manager ImmunityBioSenior Regulatory Affairs Program ManagerSummit, NJLead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes. 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.
NewRegulatory Affairs Compliance Manager PBF Energy IncRegulatory Affairs Compliance ManagerParsippany, NJ$106,787.51–$189,503.19 / yearThis role includes day-to-day management of ISCC program requirements and risk management, continuous monitoring of regulatory and system updates, and direct accountability for mass balance, conversion factors, GHG calculations, and audit readiness and execution. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills and internal peer equity will be considered in determining the selected candidate's compensation.
Staff Specialist, Regulatory Affairs Stryker CorpStaff Specialist, Regulatory AffairsMahwah, NJRemote$77,700–$129,500 / yearHowever, 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. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.
Senior Manager, Regulatory Affairs Getinge ABSenior Manager, Regulatory AffairsWayne, NJRemoteThe Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.
Director, Regulatory Affairs Eikon Therapeutics, Inc.Director, Regulatory AffairsJersey City, NJ$213,000–$257,250 / 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. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner.
NewSenior Director, Regulatory Affairs Ardelyx IncSenior Director, Regulatory AffairsNY$259,000–$317,000 / yearPartner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications. Qualifications: Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience.
Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory Affairs Ernst & Young Global LtdRisk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory AffairsNew York, NY$138,100–$315,600 / yearIf you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at ssc.customersupport@ey.com. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally: Quality Management Systems.
Director, Regulatory & Administrative Affairs - Institute for Transformative Clinical Trials Mount Sinai Health SystemDirector, Regulatory & Administrative Affairs - Institute for Transformative Clinical TrialsNew York, NY$95,450–$143,175 / yearThe Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Manager, Regulatory Affairs MTF BiologicsManager, Regulatory AffairsEdison, New JerseyFull timeThis role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits, recalls, licensing, labeling and promotional review, quality system documentation, risk management, and design control support. Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies.