- 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...issues, and risks in written and verbal format to regulatory senior leadership team and other governing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, a Senior Principal Scientist/ Senior Director , has primary responsibility for developing ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions.… 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 ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... 4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong… 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a… more
- Merck & Co. (Rahway, NJ)
- …to ensure compliance and reduction in workplace Industrial Hygiene risks.Lead global continuous improvement initiatives to improve global Industrial Hygiene ... the globe.Identify, interpret and perform impact analysis on emerging global industrial hygiene regulations, guidelines and consensus standardsAudit Industrial… more
- Merck & Co. (Rahway, NJ)
- …our existing and pipeline products to produce safe, effective, innovative medicine.The Senior Principal Scientist/ Senior Director is responsible for protocol ... meetings and preparation of manuscripts for publication in peer-reviewed journals. The Senior Director will also contribute to establishing Vaccine Clinical… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …where they live or their economic status. **POSITION OVERVIEW:** As a Sr . Director , Early Oncology Global Regulatory Affairs, you will develop and ... execute Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise Lead and cross functional… more
- Daiichi Sankyo Inc. (Basking Ridge, 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 ... Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and...issues, and risks in written and verbal format to regulatory senior leadership team and other governing… more
- Citigroup (New York, NY)
- The Regulatory Reporting role is a senior management position within the Controllers Organization that will report up through the Global Head of ... will support effective decision making in the remediation of critical gaps in regulatory reporting and bolster the team's ability to meet regulatory commitments… more
- JPMorgan Chase (Jersey City, NJ)
- …of the regulatory change management processes within Payments. As an Executive Director within the Global Regulatory Developments and Engagement (GRDE) ... advisory experience and a passion for innovation and stakeholder engagement? The Global Regulatory Developments and Engagement (GRDE) function within Payments… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products ( Sr . Director ) **Location** : Cambridge, MA or ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products… more
