Regulatory Affairs Strategist, Globalization (eIPRRA) Becton Dickinson and CoRegulatory Affairs Strategist, Globalization (eIPRRA)Franklin Lakes, NJ$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best‑practice sharing.
Regulatory Affairs Strategist, Globalization (US/ EU) Becton Dickinson and CoRegulatory Affairs Strategist, Globalization (US/ EU)Franklin Lakes, NJ$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best‑practice sharing.
Senior Specialist, Regulatory Affairs ImmunityBio IncSenior Specialist, Regulatory AffairsSummit, 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.
Sr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsJersey City, New Jersey, United States, New JerseyMonitors competitive claims, FDA’s and FTC's actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
Regulatory Affairs Project Manager Colgate-Palmolive CoRegulatory Affairs Project ManagerPiscataway, NJ$124,000–$174,000 / yearEstablished in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses - Oral Care, Personal Care, Home Care and Pet Nutrition.
Senior Manager / Associate Director, Regulatory Affairs CMC Shionogi & Co LtdSenior Manager / Associate Director, Regulatory Affairs CMCFlorham Park, NJ$140,000–$200,000 / yearServe as the primary CMC regulatory liaison with Health Authorities for designated assets, which involves guiding agency communications, creating briefing documents, handling information requests, and ensuring alignment with management on strategic or high‑risk issues before making commitments. Excellent verbal communication skills, with demonstrated ability to act as a regulatory CMC spokesperson and effectively communicate aligned regulatory CMC strategies and positions across working teams, cross‑functional forums, and senior leadership.
Senior Specialist, Regulatory Affairs ImmunityBioSenior Specialist, Regulatory AffairsSummit, 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.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)New York City, NY$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
Assistant, or Associate Professor of Drug Regulatory Affairs Long Island UniversityAssistant, or Associate Professor of Drug Regulatory AffairsBrooklyn, NY$110,001–$120,000 / yearChair, Faculty Recruitment Committee, Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, New York at ahmed.abufayyad@liu.edu. Assistant, or Associate Professor of Drug Regulatory AffairsAssistant, or Associate Professor of Drug Regulatory Affairs No. 4129 Long Island University Brooklyn, New York Pharmaceutics and Indust Sci Posted Apr 17, 2026 $110,001-$120,000.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsMORRISTOWN, NJ$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Associate Director, Regulatory Affairs BeOne Medicines AGAssociate Director, Regulatory AffairsNY$146,700–$196,700 / yearProvides strategic and operational regulatory direction on assigned projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, risk assessments, critical issue management and advice on health authority interactions. Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
Director, Regulatory Affairs - CMC Rocket Pharmaceuticals IncDirector, Regulatory Affairs - CMCCranbury, NJ$204,000–$244,000 / yearThey will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs. Rocket Pharma is seeking a Director, Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls to support the success of our gene therapy programs by serving as the global product leader for CMC regulatory strategy.
Legal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of ChinaLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearFull timeOversee 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.
Legal & 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 / yearFull timeOversee 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.
NewSenior 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.
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.
NewAssociate Director, Regulatory Affairs Contract 4D Molecular Therapeutics IncAssociate Director, Regulatory Affairs ContractNY$83–$98 / hourThe role requires working closely with 4DMT's key stakeholders, cross-functional teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of clinical trial applications, and other regulatory filings. GENERAL SUMMARY: We are seeking an experienced Associate Director, Regulatory Affairs (Contract) focusing on the management of CMC and clinical regulatory applications (domestic and international) in support of 4DMT's multiple therapeutics in development.
Director, 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.
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.
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.
Executive Director, CMC Global Regulatory Affairs Merck & Co IncExecutive Director, CMC Global Regulatory AffairsRahway, NJ$231,900–$365,000 / yearRequired Skills: Biopharmaceuticals, Confidentiality, Global Health, Manufacturing, Mentoring Staff, People Leadership, Pharmaceutical Biology, Pharmaceutical Regulatory Affairs, Project Management, Regulatory Affairs Compliance, Regulatory Compliance Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Training, Strategic Thinking. An experienced and dynamic Executive Director CMC (Chemistry, Manufacturing & Control) GRA (Global Regulatory Affairs) is sought to lead the global pharma CMC regulatory team and oversee the development and maintenance of pre- and post-approval regulatory strategies and submissions.
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.
Manager, Regulatory Affairs MTF BiologicsManager, Regulatory AffairsEdison, New Jersey$99,000–$125,000 / yearFull 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.
Sr Director of Regulatory Affairs - North America Perrigo Co PlcSr 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.
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.
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.
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.
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.
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.
Analyst, Regulatory Affairs Oscar Health IncAnalyst, Regulatory AffairsNY$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.
Director, US Advertising And Promotion, Global Regulatory Affairs SanofiDirector, US Advertising And Promotion, Global Regulatory AffairsMorristown, NJ$178,500–$257,833.33 / yearEstablishes and develops key internal relationships with therapeutic product leaders in Commercial organization, R&D and Corporate functions (e.g., Communications, Compliance, Legal) to foster open communication and teamwork. The Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs.
Director, US Advertising and Promotion, Global Regulatory Affairs SanofiDirector, US Advertising and Promotion, Global Regulatory AffairsMorristown, NJ$178,500–$257,833.33 / yearEstablishes and develops key internal relationships with therapeutic product leaders in Commercial organization, R&D and Corporate functions (e.g., Communications, Compliance, Legal) to foster open communication and teamwork. The Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs.
NewRegulatory 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.
Technology Business Partner - Regulatory Affairs Novartis AGTechnology Business Partner - Regulatory AffairsEast Hanover, NJ$65,200–$121,000 / yearExpected Annual Base Salary Range for role:Basel: 65,200.00 - 121,000.00 EUR AnnualThe salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. You will lead a global portfolio that connects strategy, architecture, and execution-empowering leaders with clear insights, enabling innovation, and ensuring technology consistently advances regulatory excellence and patient outcomes.
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 & 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.
Vice President, Food Safety, Quality & Regulatory Affairs DO & CO AGVice President, Food Safety, Quality & Regulatory AffairsJamaica, NY$200,000–$230,000 / yearThe ideal candidate is a transformational leader with extensive experience in multi-site food manufacturing, airline catering, commissary, or high-volume food production environments and a proven ability to build world-class food safety programs that protect consumers, strengthen customer partnerships, and uphold the integrity of the DO & CO brand. DO & CO is seeking an accomplished Vice President of Food Safety, Quality & Regulatory Affairs to provide executive leadership for all food safety, quality assurance, regulatory compliance, sanitation, supplier quality, and product integrity initiatives across our North American operations.
Regulatory Affairs Director - Hybrid (Bronx Office) CareSourceRegulatory Affairs Director - Hybrid (Bronx Office)NY$135,600–$237,400 / yearJob Summary: The Regulatory Affairs Director is responsible for leading activities of the Regulatory Affairs Department, including contracts, compliance, surveys, audits, investigations, reporting, plan development and renewal, credentialing, Fraud, Waste & Abuse Special Investigations, provider network and relations, regulatory updates and compliance matters. CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level.
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.
Senior Regulatory Affairs Specialist Integrated Resources, IncSenior Regulatory Affairs SpecialistJersey City, New JerseyFull timeSenior Regulatory Affairs SpecialistA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products.
NewSenior 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.
Senior Manager, Regulatory Affairs Advertising and Promotion SanofiSenior Manager, Regulatory Affairs Advertising and PromotionMorristown, NJ$122,250–$176,583.33 / yearAs the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.
Senior Manager, Regulatory Affairs Advertising And Promotion SanofiSenior Manager, Regulatory Affairs Advertising And PromotionMorristown, NJ$122,250–$176,583.33 / yearAs the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.
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, Quality Systems & Regulatory Affairs (Remote - East Coast) CEFALY TechnologyDirector, Quality Systems & Regulatory Affairs (Remote - East Coast)Darien, CTRemoteA critical priority for this role will be optimizing and expanding the company's electronic Quality Management System (eQMS), conducting comprehensive assessments of quality documentation and system effectiveness, and driving sustainable process improvements across the organization. This role is being added to strengthen organizational quality and regulatory capabilities, reduce single-point dependency risk, improve QMS sustainability, and establish scalable systems supporting long-term growth and compliance excellence.
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.
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.
NewRegulatory Affairs/Quality Affairs Specialist ElliquenceRegulatory Affairs/Quality Affairs SpecialistBALDWIN, NYFull timeCreate documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance. This role collaborates cross-functionally across the organization to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.
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.
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.