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.
Manager, Regulatory Affairs MTF BiologicsManager, Regulatory AffairsEdison, New Jersey$101,000–$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.
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.
NewDirector, Regulatory Affairs Legend Biotech CorpDirector, Regulatory AffairsSomerset, NJ$193,629–$254,137 / 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.
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 Knowledge Management Capability Lead Novartis AGRegulatory Affairs Knowledge Management Capability LeadEast Hanover, NJ$67,900–$126,100 / yearJob Description Summary#LI-Hybrid (12 days per month on-site if living within 50 miles of our London office)#LI-Remote (Homeworker if living further than 50 miles of our London office)Office Location: London (The Westworks), United KingdomAs a member of the Knowledge & Content Management Platform team, the Knowledge Management Capability Lead contributes to the strategic vision of Regulatory Affairs and supports the digitalization and centralization of Knowledge Management in RA, by overseeing one or several product(s) underlying the Capability. Team Leadership:Responsible to ensure alignment of a team with organizational goals and business priorities related to Knowledge ManagementSupport the strategic vision for the Knowledge & Content Management Platform, from a Capability levelAct as a Change Lead to drive system adoption, communication and training, at the capability level: implement change management strategies to ensure smooth adoption of technology initiatives2.
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.
Regulatory 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.
Senior 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.
Senior Manager, Regulatory Affairs - OTC GSKSenior Manager, Regulatory Affairs - OTCWarren, New Jersey$152,620–$209,852 / yearPlease include the following in your email: Use subject line: ‘Haleon Careers: Job Accommodation Request’ Your Name and contact information Requisition ID and Job Title you are interested in Location of Requisition (city/state or province/country) Description of specific accommodation you are requesting Please note: Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted. This 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).
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.
NewSr. 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.
Director, CMC Regulatory Affairs Recursion PharmaceuticalsDirector, CMC Regulatory AffairsNew York, NYRemote$228,250–$280,720 / yearPowered 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. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need.
Director, Quality Systems & Regulatory Affairs (Remote - East Coast) (Remote) CEFALY TechnologyDirector, Quality Systems & Regulatory Affairs (Remote - East Coast) (Remote)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.
Regulatory Affairs Director - Hybrid (Bronx Office) CareSourceRegulatory Affairs Director - Hybrid (Bronx Office)Bronx, 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.
Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - OncologyTarrytown, NY$128,600–$210,000 / yearDiscover your role: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
NewRegulatory Affairs Consultant ClinChoice IncRegulatory Affairs ConsultantLong Island, NYCoordinate and ensure maintenance of Brand/Market Registration Tracking databases in cooperation with affiliate, law firm and distributor counterparts, ensuring consistency and timely registrations and data integrity. Research, generate and distribute registration documentation; including formulas, specifications, Certificates of Free Sale, durability, claims substantiation, supporting declarations and artwork - according to specified local market regulations.
Director, Regulatory Affairs Recursion Pharmaceuticals IncDirector, 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.
Senior Professional Regulatory Affairs - Lifecycle Management - - Medicines Perrigo Co PlcSenior Professional Regulatory Affairs - Lifecycle Management - - MedicinesMorristown, NJProvides strategic regulatory leadership for significant post-approval supplements and annual reportable changes, remediation, and compliance risks, ensuring lifecycle delivery protects compliance posture, approved application commitments, and supply continuity. Lead assessment and management of complex and high-risk post-approval changes across the US market and/or global markets, defining data needs, appropriate FDA reporting category, submission strategy, and dossier updates.