Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Associate Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$166,720–$250,080 / yearFull timeThe Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
Director, 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.
Director, Regulatory Affairs, Companion Diagnostics Daiichi Sankyo, Inc.Director, Regulatory Affairs, Companion DiagnosticsBasking Ridge, NJ$184,240–$276,360 / yearFull timeCDx RA Strategy: Represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically: Use of CTA/CDx within clinical trials. Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
NewRegulatory Affairs Strategist Aquestive Therapeutics Inc.Regulatory Affairs StrategistWarren, NJThis role serves as a key liaison between the company and regulatory agencies, ensuring compliance with applicable regulations while facilitating timely submissions for clinical trials, marketing authorizations, and post-approval changes. Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, the strategist provides regulatory guidance throughout all phases of product development.
Director, Omnichannel - Global Oncology Medical Affairs Daiichi Sankyo, Inc.Director, Omnichannel - Global Oncology Medical AffairsBasking Ridge, NJ$189,600–$284,400 / yearFull timeDemonstrated experience in content management strategy including digitalizing and modularizing medical content; Proven leadership skills in a cross-functional global team environment; Experience in managing cross-functional teams, collaborating with diverse stakeholders and with the ability to influence without authority; Strong knowledge of industry best practices; Strong understanding of regulatory requirements and compliance considerations in the pharmaceutical industry; Excellent leadership and communication skills, with the ability to partner and work with teams across regions and functions required. Cross-team Collaboration: Work with a cross-functional medical affairs team including Franchise and GMAT leads, Region (Medical, Omnichannel, and Analytics) leads, Affiliate Medical Directors, Content Team, Scientific Engagement Team, Analytics and Data Teams to enable medical engagement strategy (i.e. medical journeys with associated outcomes) and enable capability pull-through.
Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & GovernanceBasking Ridge, NJ$271,500–$452,500 / yearFull timeEnsure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
EHS, QMS & Regulatory Specialist Synerfac Technical StaffingEHS, QMS & Regulatory SpecialistCarlstadt, NJNice to have: direct experience with ChemStewards or a comparable EHS&S system (Responsible Care®, RC14001); experience in dispersion, emulsion, or polymer manufacturing; prior work at a growing or newly acquired manufacturer where systems were being built, not inherited. You'll spend time in production areas requiring PPE (safety glasses, footwear, gloves, and periodic respiratory protection), and should be comfortable standing/walking for extended periods, climbing stairs and ladders, and occasionally lifting up to 50 lbs.
Product Regulatory Coordinator JouléProduct Regulatory CoordinatorLyndhurst, NJ$27–$35 / hourOversee and continuously improve administrative processes, identifying opportunities to streamline workflows, enhance data management systems, and support scalability for future business needs. Strong proficiency in Microsoft Office applications, particularly Excel, Word, and PowerPoint, with the ability to manage data, prepare reports, and maintain documentation.
Chief Diversity Officer LaGuardia Community CollegeChief Diversity OfficerQueens, NY$131,440–$141,325 / yearFull timeLaGuardia ranked fifth among U.S. community colleges in economic mobility – moving low-income students into the middle class and beyond – in studies by Stanford University (2017) and the Brookings Institution (2020). Reporting to the President, the Chief Diversity Officer (CDO) is responsible for overseeing and managing the diversity and compliance staff, campus diversity and compliance initiatives, federal, state, and CUNY policies/regulations while maintaining the highest level of confidentiality and integrity with faculty, staff, and students.
Director, Global Labeling Strategist Daiichi Sankyo, Inc.Director, Global Labeling StrategistBasking Ridge, NJ$193,040–$289,560 / yearFull timeServe as a role model for less experienced members of GRA labeling, Labeling Content Management: Manage the preparation, review, and approval of labeling content (including target labeling) for new product submissions, variations, and updates for marketed products, ensuring accuracy, consistency, and regulatory compliance. Cross-functional Collaboration: Serve as the regulatory labeling lead on cross-functional teams, working closely with Regulatory Affairs, Clinical, Medical Affairs, Safety, Legal, and Commercial to enable timely achievement of labeling milestones and project objectives.
Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.Associate Director, Consumer US MarketingBasking Ridge, NJ$162,400–$243,600 / yearFull timeWith a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
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).
Director, Healthcare Compliance Aquestive Therapeutics Inc.Director, Healthcare ComplianceWarren Twp, NJReporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions. Key Internal Partners: Legal, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, Quality, Patient Services, and Executive Leadership.
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.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
NewRecords and Information Specialist ECLARORecords and Information SpecialistWHITE PLAINS, NY$1 / hourThe Records Assistant role supports the Corporate Records team by reviewing, preparing, digitizing, and classifying hardcopy documents for inclusion in the organization's Records Management System. Work in accordance with client's records and content management policies Under the supervision of Digital warehouse and the Law department, assist in the creation of a digital collection for archived hard copy law cases.
Medical Science Liaison, Hematology - Northeast Jazz PharmaceuticalsMedical Science Liaison, Hematology - NortheastNew York, NYRemote$160,000–$240,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Consistently acts to enhance Jazz Pharmaceuticals’ image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information.
NewProject Coordinator ECLAROProject CoordinatorWhite Plains, NYThe Project Coordinator will act as a liaison between the client Renewables team and key internal and external stakeholders, including Finance, Procurement, Legal, Community Affairs, Engineering, and other supporting departments, to track activities, facilitate communication, generate reports, and help keep day-to-day activities and projects moving forward. Proficiency in Microsoft Office Suite (Outlook, Excel, Word, PowerPoint, Teams) and ability to quickly learn MS 365 tools (SharePoint List, Power Automate) to develop concise project reports and dashboards.
Director Corporate Communications JouléDirector Corporate CommunicationsParsippany, NJ$170,000–$200,000 / yearThe Director will shape corporate storytelling, executive communications, media relations, employee engagement, and digital strategy while translating complex scientific and clinical information into clear, compelling messaging. This is an opportunity to take ownership of corporate communications for a growing, publicly traded biopharmaceutical company and work closely with executive leadership on high visibility initiatives.