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.
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.
Director, Regulatory Affairs Americas , L''Oréal Research & Innovation L'Oreal USA IncDirector, Regulatory Affairs Americas , L''Oréal Research & InnovationClark, NJ$126,900–$184,000 / yearIn this pivotal role, you will bridge the gap between complex legislation and high-stakes business growth, defending our regulatory policies before major authorities like the FDA and CARB while ensuring our groundbreaking products reach the hands of our consumers safely and swiftly. A Day in the Life: As a strategic leader in Regulatory Affairs, your responsibilities include: Regulatory Compliance Excellence: Direct the strategy to ensure all products placed on the market comply with local, country, and federal regulations across the Americas zone.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
EG-140 - Regulatory Affairs / Medical Writing Bristol-Myers Squibb CoEG-140 - Regulatory Affairs / Medical WritingPrinceton, NJ$170,880–$207,061 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans).
Senior Scientist I, Regulatory Affairs, L''Oréal Research & Innovation L'Oreal USA IncSenior Scientist I, Regulatory Affairs, L''Oréal Research & InnovationClark, NJ$77,400–$110,300 / yearIn this role, you will be a pivotal force in ensuring that our innovations reach consumers safely, compliantly, and confidently - navigating the complex global regulatory landscape so our scientists and product developers can focus on what they do best: pioneering the future of beauty. Manage and prioritize regional regulatory projects, collaborating across countries and cross-functional teams to align timelines, resolve compliance challenges, and drive decisions that keep product launches on track.
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.
Vice President, Global Regulatory Affairs, Team Lead, Strategy Genmab ASVice President, Global Regulatory Affairs, Team Lead, StrategyPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. The Vice President, Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory Affairs, responsible for managing the regulatory strategy and regulatory deliverables for a portfolio of assets across all stages of 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.
Regulatory Affairs Coordinator Capital HealthRegulatory Affairs CoordinatorHopewell, New JerseySUMMARY: Reporting to the Manager of Regulatory Affairs, coordinates organization-wide as well as program-specific activities related to the regulatory process and the respective governing bodies, including NJ Department of Health, Centers for Medicare and Medicaid Services (CMS), DNV and others. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
Senior Regulatory Affairs Specialist OrganOxSenior Regulatory Affairs SpecialistMadison, NJ$120,000–$137,000 / yearIt has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Vice President, Regulatory Affairs, Specialty Surgery Integra LifeSciences Holdings Corp.Vice President, Regulatory Affairs, Specialty SurgeryPlainsboro, NJ$225,400–$316,250 / yearDemonstrated success developing and executing regulatory strategies within the MedTech industry, preferably for specialty surgery, implantable devices, neurosurgical, reconstruction, biologics, combination products, or related product portfolios, including experience with complex submissions such as Class III PMA, IDE, pre-submissions, 510(k)s, technical files, design dossiers, or international registrations. This role partners with Global Regulatory Affairs leadership, Specialty Surgery business leaders, Quality, Operations, Product Development, Commercial, Legal, Medical Affairs, and other stakeholders to develop and execute regulatory strategies that support product development, submissions, lifecycle management, advertising and promotion review, and global registrations for the division.
Legal Counsel of Corporate and Regulatory Affairs Atlantic Health System IncLegal Counsel of Corporate and Regulatory AffairsMorristown, NJDraft, review, negotiate, and interpret a broad range of commercial agreements, including professional services agreements, physician and provider arrangements, purchasing and supply chain contracts, consulting agreements, confidentiality agreements, technology and software agreements, revenue-generating partnerships, and other operational contracts. As a member of a collaborative in-house legal department, Counsel will work closely with executive leadership, clinical and operational teams, compliance professionals, and business partners to develop practical legal solutions that advance innovation while ensuring regulatory compliance and protecting the organization''s mission.
Regulatory Affairs Associate Aurobindo Pharma LtdRegulatory Affairs AssociateEast Windsor, NJDeprecated : preg_replace_callback(): Passing null to parameter #3 ($subject) of type array|string is deprecated in C:\api\public\classes\StringCleaner.class.php on line 100 .
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.
Director, Regulatory Affairs - CMC PTC Therapeutics IncDirector, Regulatory Affairs - CMCWarren, NJ$193,500–$243,600 / yearWorks with GRA functions to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality. This position works cross-functionally with Regulatory Affairs, Technical Operations, Quality, and program teams to facilitate the completion of regulatory submissions through regulatory approvals in accordance with company goals and timelines.
Professional Regulatory Affairs - Lifecycle Management - Non-Medicines Perrigo Co PlcProfessional Regulatory Affairs - Lifecycle Management - Non-MedicinesMorristown, NJWe are excited to recruit a Regulatory Affairs Professional within Non-Medicinal Lifecycle Management, you will play an important role in supporting Perrigos non medicinal portfolio including cosmetics, VMS, general products and other non-medicinal classifications such as medical devices across the product lifecycle. You will be responsible for managing lifecycle management activities, including the preparation, maintenance and delivery of regulatory documentation, product information files, technical files, notifications, registrations and supporting records in line with global requirements and business priorities.
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.
Director, Regulatory Affairs Legend Biotech CorpDirector, Regulatory AffairsSomerset, NJ$168,372–$220,988 / yearServes as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.
NewDirector, Regulatory Affairs Legend Biotech USDirector, Regulatory AffairsSomerset, New JerseyServes as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.