- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global ... assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners closely with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global and regional ... 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)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and prioritize improvement opportunities with the greatest impact.Process Optimization Lead initiatives to standardize, simplify, and optimize core processes across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience (UDX) strategies. In this position, the Non-Regulated Implementation Services Lead will collaborate closely with cross-functional Global DX teams, ... 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)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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. (Bernards, NJ)
- …that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are ... collaboration with the Global RD/PV QA team.RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs) by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness. Lead internal and external (especially regulatory , but also… 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 ... Development will be responsible for providing legal counsel to Daiichi Sankyo's Global Business Development department and handle all legal aspects of licensing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of ... 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)
- …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. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Global Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and support for the business aspects ... 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. (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 ... to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across… 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 ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development ... 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)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.Act as a Site MES SME to support...the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical industry.Excellent ... creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and fiscal awareness.Project Management… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Global Regulatory Lead **Location** : Bridgewater, NJ / Morristown, NJ/ Cambridge, MA (hybrid) **About the Job:** Are you ready to shape the ... accelerate progress. Join our Immunology & Inflammation Regulatory Team as Global Regulatory Lead and you'll be responsible for the development &… more
