Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
NewImport Manager (Licensed) JobotImport Manager (Licensed)Moonachie, NJ$90,000–$95,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Our client, a growing international logistics and customs brokerage organization, is seeking an experienced Licensed Customs Import Manager to lead import operations and ensure compliance with U.S. Customs regulations.
NewRegulatory Affairs Senior Associate electroCore IncRegulatory Affairs Senior AssociateRockaway, NJThe position provides regulatory strategy input, prepares and maintains submission and technical documentation content, evaluates product and labeling changes, supports post-market and vigilance obligations, and partners cross-functionally to ensure compliant, timely execution of business objectives. • Provide practical regulatory strategy input for new products, product modifications, labeling changes, software/app updates, manufacturing changes, supplier changes, and market expansion activities.
NewCustoms Entry Writer JobotCustoms Entry WriterMoonachie, NJ$26–$32 / hourThe successful candidate will be responsible for preparing, compiling and managing all documentation and records required to clear goods through the United States Customs Service (USCS), including negotiating with, and presenting declarations to, foreign and domestic customs officials. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
NewCase Manager Encompass Health Rehabilitation Hospital of Tinton Falls, a Joint Venture with Monmouth Medical CenterCase ManagerFords, NJJoin Encompass Health, where being a Case Manager goes beyond just a job; it positions you as a vital link between exceptional care and the transformative impact on each patient's journey. Our achievements include being named one of the "World's Most Admired Companies" and receiving the Fortune 100 Best Companies to Work For® Award, among other accolades, which is nothing short of amazing.
Clinical Study Manager, Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Clinical OperationsBasking Ridge, NJ$136,080–$204,120 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
NewClinical Study Manager, Global Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical OperationsBasking Ridge, NJ$136,080–$204,120 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Analytical Science Manager JouléAnalytical Science ManagerParsippany, NJ$100,000–$135,000 / yearSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Partner with Quality Assurance, Regulatory Affairs, and external test sites to support technology transfers, and analytical method validations.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
NewPharmaceutical Field Sales Representative Inizio EngagePharmaceutical Field Sales RepresentativeJersey City, NJ$52,000–$96,000Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Maintain an in-depth and knowledge of related disease state and market dynamics, quality programs, health information technology, care trends or other account-specific considerations that allow engagement in meaningful dialogue and adding value when calling on customers.
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.
NewEntry Level Account Manager - Frontier Sales OP ManagementEntry Level Account Manager - Frontier SalesValley Stream, NYFull timeAs an Entry Level Account Manager for Frontier Communications, you’ll talk to real people, share real solutions, and make real connections - all while leveling up your career, learning to be a leader, and making a difference in the lives of consumers. Serve as the main point of contact on behalf of Frontier and communicate directly with residential customers to promote Frontier’s telecommunications products and services .
Manager, Regulatory Lifecycle Maintenance ImmunityBio IncManager, Regulatory Lifecycle MaintenanceSummit, 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 Manager of Entry-Level Recruitment Fox Rothschild LLPSenior Manager of Entry-Level RecruitmentNY$160,000–$190,000 / yearThis role leads the law school outreach strategy, manages the summer associate program lifecycle, oversees entry‑level associate hiring and onboarding, and partners with Department Chairs, Office Managing Partners, and the Talent team to ensure the firm attracts, selects, and retains top early‑career legal talent. As a member of Fox Rothschild's Legal Talent team, the Senior Manager of Entry‑Level Recruitment is responsible for the end‑to‑end strategy, execution, and continuous improvement of the firm's law student and entry‑level hiring programs across all offices.
Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu LtdDigital Assets Regulatory Management ManagerCT$144,600–$265,100 / yearCandidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. As a Manager, you will have opportunities to: Oversee and direct end-to-end client projects focused on digital asset risk, regulatory compliance, and licensing, owning project scoping, resource allocation, timelines, quality, and deliverables.
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.
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.
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.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals IncManager, Regulatory Affairs, Advertising & PromotionNY$128,600–$210,000 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Regulatory Affairs Senior Manager LancesoftRegulatory Affairs Senior ManagerWarren, NJJob Purpose: The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle Maintenance for the portfolio of products defined by the US Business Units. Provides advice on US-specific activities and ways of working and processes; Proactively identify potential risks and manage impact of regulatory changes within defined scope of.
Senior Manager, Regulatory Affairs Quidelortho CorpSenior Manager, Regulatory AffairsNJRemoteThis position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL The Responsibilities Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
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 Manager Regulatory Affairs US Advertising and Promotion - US Specialty AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - US SpecialtyFlorham Park, NJOversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Regulatory 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.
Senior Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs ManagerNew York, NY$90,000–$140,000 / yearThe 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.
NewSenior Manager, Regulatory Affairs QuidelOrthoSenior Manager, Regulatory AffairsNewark, NJRemoteReviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
NewSenior 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.
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.
Manager, Regulatory Affairs Strategy - Immunology & Inflammation Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - Immunology & InflammationTARRYTOWN, NY$128,600–$210,000 / yearA typical day might include the following: 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.
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.
Regulatory Affairs Manager Actalent IncRegulatory Affairs ManagerNJ$90,000–$115,000 / yearOversee the preparation, review, and maintenance of regulatory documents, including TDS, SDS, allergen and GMO statements, nutritional and natural certifications, Non-GMO Project forms, Kosher and Halal certifications, certificates of origin (COO), Prop 65 documentation, flavor labeling, TTB submissions, and related materials. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Civil Engineer (Entry Level – Land Development) | Red Bank, NJ | Bohler BohlerCivil Engineer (Entry Level – Land Development) | Red Bank, NJ | BohlerRed Bank, New JerseyIn this role, you will work closely with engineers, designers, and project managers to bring exciting land development projects to life, including site planning, grading, utilities, and stormwater management. Work on real land development projects, design real sites, and grow through hands-on experience, professional development, and mentorship from engineers who want to see you succeed.
Manager, Regulatory Policy & Intelligence Insmed IncManager, Regulatory Policy & IntelligenceNJRemote$133,000–$173,000 / yearReporting to the Senior Director, Regulatory Affairs Strategist, you will serve as a critical resource for global regulatory intelligence - monitoring the evolving regulatory landscape, managing complex policy projects, and ensuring key stakeholders across Insmed are equipped with the regulatory insights needed to make sound, strategic decisions. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications.
NewEntry Level LMSW Careers In NonprofitsEntry Level LMSWNew York City, New YorkThe Clinical Coordinator manages and supervises a team of Case Managers, ensuring the utilization of Harm Reduction and Housing First strategies and other best-practice clinical interventions to ensure the highest quality care for clients. Promote effective strategies for case management following Housing First, Harm Reduction, Crisis Prevention Institute (CPI), Motivational Interviewing and trauma-informed care models of practice.
Scientific - Global Regulatory CMC Manager TechDigital CorporationScientific - Global Regulatory CMC ManagerSummit, NJ2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
NewManager, Regulatory Quality, Vaccines Pfizer IncManager, Regulatory Quality, VaccinesNew York, NY$88,500–$147,500 / yearYou will operate in a highly cross-functional environment, partnering closely with stakeholders across Research & Development and Vaccines, to ensure regulatory deliverables are completed on time, in compliance with current regulatory guidance, and in a full, submission-ready format. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.
Legal Engineering Manager, In-House (Litigation/Regulatory) HarveyLegal Engineering Manager, In-House (Litigation/Regulatory)New York, New YorkIn addition to managing and developing the team, you will work directly with strategic customers, help shape Harvey’s go-to-market approach, and partner cross-functionally with Product, Marketing, Enablement, and Engineering to improve how Harvey serves the legal industry. Qualified lawyer with 7+ PQE, including significant experience practicing litigation, regulatory, investigations, compliance, white-collar defense, enforcement, employment litigation, financial regulatory matters, government investigations, or other contentious legal work, including experience working in-house.
Legal Engineering Manager, In-House (Litigation/Regulatory) Counsel AI CorpLegal Engineering Manager, In-House (Litigation/Regulatory)NY$315,000–$385,000 / yearIn addition to managing and developing the team, you will work directly with strategic customers, help shape Harvey's go-to-market approach, and partner cross-functionally with Product, Marketing, Enablement, and Engineering to improve how Harvey serves the legal industry. Qualified lawyer with 7+ PQE, including significant experience practicing litigation, regulatory, investigations, compliance, white-collar defense, enforcement, employment litigation, financial regulatory matters, government investigations, or other contentious legal work, including experience working in-house.
NewEntry Level Water Resources Designer Vanasse Hangen Brustlin IncEntry Level Water Resources DesignerNew York City, NY$85,000–$88,000 / yearProject work may include stormwater management and drainage design, hydrologic and hydraulic analyses, site civil design support, bridge and culvert hydraulics, scour evaluations, coastal and flood resilience assignments, MS4 / stormwater program support, permitting, and field investigations. Coursework, internship, research, or project experience related to stormwater management, hydrology, hydraulics, water quality, environmental engineering, civil/site design, coastal resilience, or watershed management preferred.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
NewDirector, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
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.
Regulatory Manager - Cardiology Columbia UniversityRegulatory Manager - CardiologyNew York, NY$71,400–$73,000 / yearAbility to work with a variety of individuals and groups in a constructive and respectful manner while appreciating the unique contributions of an inclusive workforce that brings together the talents of people across multiple identities. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training.
NewEntry Level Water Resources Designer VHBEntry Level Water Resources DesignerNew York, NY$85,000–$88,000 / yearProject work may include stormwater management and drainage design, hydrologic and hydraulic analyses, site civil design support, bridge and culvert hydraulics, scour evaluations, coastal and flood resilience assignments, MS4 / stormwater program support, permitting, and field investigations. Coursework, internship, research, or project experience related to stormwater management, hydrology, hydraulics, water quality, environmental engineering, civil/site design, coastal resilience, or watershed management preferred.
Sr. Manager, Regulatory & Compliance Reporting Philip Morris International U.S.Sr. Manager, Regulatory & Compliance ReportingStamford, CTFull time10+ years of progressive experience in regulatory reporting, excise/compliance operations, licensing, or regulatory tax operations, 5+ years of experience working in a highly regulated nicotine/tobacco environment (smokeless tobacco, modern oral nicotine pouches, heated tobacco, ENDS, or adjacent regulated consumer goods). Position Overview: The Senior Manager, Regulatory & Compliance Reporting leads U.S. federal and state tobacco/nicotine regulatory reporting and the full lifecycle of tax-related licensing and permits for a multi-entity, multi-site smoke-free and smokeless portfolio (e.g., nicotine pouches, traditional smokeless tobacco, heated tobacco).
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.