- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... that DS is prepared to meet new or proposed global regulatory requirements and that DS has...collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. Regulatory PolicyScans… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... functional RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...medicines. You will lead a global regulatory team to… more
- Merck & Co. (North Wales, PA)
- …Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting ... Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and...Global Liaison.Participates as an active member on the Global Regulatory Team. They will attend cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate...to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan.Daiichi Sankyo, Inc. is an… more
- Merck & Co. (Rahway, NJ)
- …with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's ... final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …to-be-marketed productsResponsibilitiesIn close collaboration with Regulatory project leads in the US , EU, and Japan, the Director , Regulatory Labeling ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...to internal stakeholders for successful development and implementation of global regulatory labeling strategy for Insmed marketed… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical, life sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI algorithms ... diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! -...across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include: Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational medicinal product dossiers (IMPD), ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide… more
- Merck & Co. (Rahway, NJ)
- …Coordinate & facilitate upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology dept. (ie-L3, ... submissions, timelines, development of deliverables for markets-- Partner closely with Global Tumor/Brand teams to assimilate L3 Next outputs to identify strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …partner companies for the development and approval of US , EU and global CCDS documents for regulatory filings and HA labeling discussions. Collaborate with ... centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Associate Director , Medical Operations, Innovation and Emerging Projects (AD, IEP) is a role within Global Medical and Value ... Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, Innovation and Emerging Projects Lead.The AD, IEP is an… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- …understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the ... chemical and biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... FDA, EU EMEA, MHRA etc.,).Develop and maintain an effective working relationship with US FDA and other international bodies.Support the global quality annual… more
- Merck & Co. (Durham, NC)
- …our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug substance manufacturing operation's ... operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and qualification… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, … more
- Eisai, Inc (NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... and governance meetings and lead processes improvement initiatives as required.Report to Director on issues and global strategies.Manage, mentor and develop… more
