NewDirector, Global Regulatory Affairs (GRL) Daiichi Sankyo, Inc.Director, Global Regulatory Affairs (GRL)Basking Ridge, NJ$193,040–$289,560 / yearFull timeThe GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements.
NewSenior Director, Regulatory Affairs Clinical Dynamix, Inc.Senior Director, Regulatory AffairsJersey City, NJThe Senior Director will represent Company in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department.
NewAssociate Director, Global Oncology Medical Affairs, Early Pipeline Daiichi Sankyo, Inc.Associate Director, Global Oncology Medical Affairs, Early PipelineBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
Senior Director, Global Oncology Medical Affairs Daiichi Sankyo, Inc.Senior Director, Global Oncology Medical AffairsBasking Ridge, NJ$242,700–$404,500 / yearFull timeResponsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound or therapeutic area and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.
Travel Nurse RN - Hospice - $2,848 per week HonorVet TechnologiesTravel Nurse RN - Hospice - $2,848 per weekBasking Ridge, NJAs a Joint Commission-certified clinical staffing agency , we deliver unmatched expertise in placing top-tier healthcare professionals—RNs, LPNs/LVNs, CNAs/CMAs, and NPs—across diverse facilities, including hospitals, clinics, rehabilitation centers, old-age homes, schools, correctional facilities, and more. Founded in 2015, HonorVet Technologies stands as a Service-Disabled Veteran-Owned Small Business (SDVOSB) , proudly certified by NaVOBA and the U.S. Department of Veterans Affairs .
NewPsychiatric Mental Health Nurse Practitioner (PMHNP) Mitchell MartinPsychiatric Mental Health Nurse Practitioner (PMHNP)Asbury Park, NJ$90–$100 / hourBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. • The Psychiatric Mental Health Nurse Practitioner (PMHNP) is responsible for providing comprehensive outpatient psychiatric care.
Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.Associate Director, Companion Diagnostics LeaderBasking Ridge, NJ$166,720–$250,080 / yearFull timeContributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection.
NewExecutive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJThe Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.
NewAssociate, Global Compliance External Engagement Daiichi SankyoAssociate, Global Compliance External EngagementBasking Ridge, NJRemoteContractorConduct independent initial review (“first line review”) of all planned CBER requests originating from DSI Business Requestors to determine if they (1) require CBER review and (2) if proposed engagements comply with applicable healthcare laws/regulations, internal policy and procedure requirements. Interact directly and frequently with CBER Committee Reviewers, Local Country-level Reviewers, and Business Requestors to assist with questions related to the review of CBER submissions.
Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJ$30–$36 / hourThis role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.
Associate Director, Commercial Regulatory Affairs Bristol Myers SquibbAssociate Director, Commercial Regulatory AffairsPrinceton, NJ$173,350–$210,058 / yearResponsibilities include: Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area. Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.
Manager - Quality & Regulatory Affairs EnvistaManager - Quality & Regulatory AffairsMahwah, NJEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Associate Director/Director, Regulatory Affairs Advertising & Promotions Tris PharmaAssociate Director/Director, Regulatory Affairs Advertising & PromotionsMonmouth Junction, NJ$160,000–$180,000 / yearTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. Associate Director- PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED.
Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy InsmedorporatedSenior Director, Regulatory Affairs, Global Regulatory Lead - Development StrategyNew JerseyRemoteYou will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.
Sr. Regulatory Affairs Specialist Integrated Resources, IncSr. Regulatory Affairs SpecialistSouth Brunswick, New JerseyFull timeA 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.
Regulatory Affairs Manager Integrated Resources, IncRegulatory Affairs ManagerWoodcliff Lake, New JerseyFull timeCandidate should be comfortable working independently to create Health Authority correspondence (including request for Health Authority consultations), and attending specific project team meetings (such as Clinical Study Team Meetings) as the Regulatory Affairs Representative and providing guidance to project teams on all areas of pharmaceutical drug development (ICH, 21CFR). Manager, Global Regulatory Strategy (GRS) will be a forward-facing role, representing GRS on project teams and communicating strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial).
NewUS Regulatory Affairs Lead – Allergy (Senior Director) ChattemUS Regulatory Affairs Lead – Allergy (Senior Director)Morristown, New JerseyOversight of labeling strategy for assigned products, including creation/testing of Drug Facts Labeling for new product launches (label comprehension and self-selection studies) and assessing/reviewing/approving label changes to marketed products. Develop and execute regulatory strategies for product launches, lead FDA interactions, oversee product labeling and lifecycle maintenance, ensure regulatory compliance, and balance innovation initiatives with ongoing support for existing products while assessing the impact of changing regulations.
NewAssociate Director, Regulatory Affairs (CMC) InsmedorporatedAssociate Director, Regulatory Affairs (CMC)New JerseyRemoteReporting to the Senior Director, Regulatory Affairs CMC, EMEA, you’ll have responsibility for leading CMC regulatory strategy development and implementation that incorporates risk identification and mitigation for assigned development and post approval programs to achieve regulatory approvals in the EMEA region. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.
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.
Associate Director, Regulatory Affairs InsmedorporatedAssociate Director, Regulatory AffairsNew JerseyRemoteYou’ll also: Work closely with a clinical regulatory CRO, regional regulatory experts, and company’s SMEs, develop and execute global regulatory strategies supporting Clinical Trial Applications (CTAs), INDs, Clinical Trial Notifications (CTNs), and other clinical trial authorizations across assigned regions. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.