- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... you ready to experiment with us? The Position The Director Channel Strategy & Planning will play a critical...Leadership Decision Support o Provide one unified NNI and global voice and point of voice to leadership to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in...for the US marketing initiatives in the context of global marketing. Coordinates closely campaign development, competitive defense, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... 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)
- …rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... implementation of a quality strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty… 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)
- …will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents ... 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
- Bausch Health (Bridgewater, NJ)
- …writing CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy,… more
- Daiichi Sankyo Inc. (Basking Ridge, 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...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… 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 Device Development and Commercialization process.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- J&J Family of Companies (Raritan, NJ)
- …step of the way. Learn more at https://www.jnj.com/innovative-medicine We are seeking a Director , Global Medical Affairs Strategy & Execution in Oncology. ... Primary Responsibilities include, but are not limited to: The Director , Global Medical Affairs Strategy...Medical Affairs directors, Janssen R&D clinical scientists, global and regional marketing directors, regulatory leaders,… more
- J&J Family of Companies (Raritan, NJ)
- …of America **Job Description:** Johnson and Johnson is currently seeking a **Medical Director , Global Medical Affairs , Biosurgery located** in **Raritan, ... with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & Compliance, Preclinical, Health… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... Join our global diversified pharmaceutical company enriching lives through our...regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... + Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + Createahighperformingteamenvironmentandacohesiveculturedrivenbyvaluesof… more
