- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… more
- Pall (Miami, FL)
- …and innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... turn ideas into impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Global Director of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is ... seeking a Global Director...with Site MSAT, Manufacturing Operations, Quality, Process Development, and Regulatory to facilitate seamless implementation of process changes and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity ( Global R&D & PV QA) ensures high ... solutions, integrates AI technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Rahway, NJ)
- …and project delivery.A complete understanding of ICH GCP and Global /Regional/Local regulatory requirements is required.Strong Communication skills requiring ... Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in...scope for GCTO country operations.Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready… more
- Repligen (PA)
- OverviewThe Director , Global Payroll will lead the development and execution of Repligen's global payroll strategy tosupport a growing global workforce. ... & Competencies Deep knowledge of international payroll legislation, tax compliance, and regulatory environments. Expertise in global payroll systems such as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Twist BioScience (South San Francisco, CA)
- Twist Bioscience is seeking a visionary and results-oriented leader to lead our global marketing efforts and drive sustainable growth. The Sr Director , Marketing ... is responsible for leading all aspects of Twist's global marketing activities. This person will plan, develop and...launching new products; and interfacing with customers. The Sr Director , Marketing also will lead growth marketing, social media… more
- Eisai, Inc (Raleigh, NC)
- …more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial, ... more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial,… more
- Pall (Miami, FL)
- …innovation.Learn about the Danaher Business System which makes everything possible. Director Global Supplier QualityJob Description SummaryProvide quality ... turn ideas into impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on… more
- Merck & Co. (Rahway, NJ)
- …and to share knowledge of relevant findings with key stakeholdersServe as the global topic owner for regulatory inspections, audit & inspection CAPAs, and ... aligned with our high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract… more
- Twist BioScience (South San Francisco, CA)
- … concepts.Ability to travel as required to support global biomanufacturing sites.Preferred QualificationsExperience with specific biopharmaceutical manufacturing ... Director /Sr. Director , Manufacturing Execution System (MES)...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Formation Bio (New York, NY)
- …clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a ... sites. Regulatory Compliance & Submissions Ensure all CMC activities comply with global regulatory expectations (eg, FDA, EMA, ICH); author and review … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is ... focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team of engineers and technical staff to… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... every aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to identify opportunities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Genmab (NJ)
- …for audits and inspections.Ensure adherence to GCP, GDMP, ICH, and global regulatory requirements.RequirementsBachelor's degree in a scientific, technical, or ... and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… more
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