- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient ... regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... business and distribution license applications and renewals and acting as lead paralegal support and coordinator of legal matters, under attorney supervision,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... Oversight Management:Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of post-law school experience required- 4 or More Years experience in regulatory , compliance , and legal matters relating to investigational products, product ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years of post-law school experience required- 7 or More Years experience in regulatory , compliance , and legal matters relating to pricing and Market Access ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to meet business objectives.Support Investigations team by providing quality and compliance input for continuous improvement; and remediation's. Lead continuous ... requirements.Strive to reduce non-conformances in supported areas by dedicatedly driving compliance .Ensure readiness of records for regulatory inspections and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a fast paced and dynamic, growing environment.Strong understanding of regulatory and compliance requirementsExcellent oral and written communication skills ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- J&J Family of Companies (Raritan, NJ)
- …Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Lead , Technology Regulatory Compliance Business Operations to join our ... At Johnson & Johnson, we all belong. The Technology Regulatory Compliance (TRC) Business Operations Lead supports group functional operations and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... areas centered around rare diseases and immune disorders. **Summary** The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Bristol Myers Squibb (Summit, NJ)
- …standard support and analytical leadership for the CT GO teams. **RESPONSIBILITIES:** + Lead the Cell Therapy Analytical Science & Technology team for BMS ... Demonstrated decision making and problem-solving capabilities relative to Quality, compliance , technical considerations, and regulatory requirements are… more
- Sanofi Group (Morristown, NJ)
- …innovation, focus on seamless integration and problem-solving for deployed solutions and lead industry-leading efforts in security, privacy, compliance , and risk ... **Innovation Solutions Lead ** Location: Morristown, NJ **_About the Job_** As...position operates at the intersection of Sanofi's Digital, IT, Regulatory , R&D, and Commercial Functions, and requires significant collaboration… more
