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.
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.
Regulatory 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.
NewSenior Manager, Regulatory Affairs Spyre Therapeutics IncSenior Manager, Regulatory AffairsNY$160,000–$176,000 / yearHealth Authority Activities: Support health authority interactions and meeting preparation with the Associate Director and Regulatory Affairs leadership by coordinating cross-functional input, contributing to briefing materials, managing response development, and ensuring commitments and follow-up actions are completed. You will independently manage assigned deliverables, including submission planning and execution, document preparation and review and CRO oversight, while progressively assuming day-to-day regulatory leadership for designated studies within the overall program direction and regulatory strategy led by the Associate Director.
NewProfessional 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.
Regulatory 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.
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.
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 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.
Quality Assurance & Regulatory Affairs Manager Marcum SearchQuality Assurance & Regulatory Affairs ManagerNew York, NY$140,000–$150,000 / yearThis hands-on role supports product development, supplier quality, regulatory submissions, import compliance, product testing, and labeling review while enabling innovation and speed to market. CBIZ Talent Solutions is seeking an experienced Quality Assurance/Regulatory Affairs Manager for our CPG client in Midtown Manhattan.
Senior 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.
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.
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.
Analyst, Regulatory Affairs Oscar Health IncAnalyst, 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.
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 Technician - Food Labeling HiFyveRegulatory Affairs Technician - Food LabelingHicksville, New YorkWe're looking for an experienced Regulatory Affairs Technician to support food labeling, product specifications, and regulatory compliance for a variety of branded, private-label, and bulk food products. This position works closely with Product Development, Quality, Sales, and Art teams to ensure labels, packaging, specifications, and product documentation meet U.S., Canadian, and customer requirements.
NewSenior Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs ManagerNew York, NY$100–$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.
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.
Director, Regulatory Affairs - Global Cyber Security Royal Bank of CanadaDirector, Regulatory Affairs - Global Cyber SecurityJersey City, New JerseyIdentify regulatory gaps in RBC's cybersecurity program compared to NYDFS Part 500 and NIST baseline expectations; coordinate remediation with first and second lines of defense and track progress to closure. Maintaining a workplace where our employees feel supported to perform at their best, effectively collaborate, drive innovation, and grow professionally helps to bring our Purpose to life and create value for our clients and communities.
NewDirector, 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.