- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Merck & Co. (Rahway, NJ)
- …Skills: Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs ... Job DescriptionThe Associate Director, Regulatory Affairs , supports products in the...and collaboration skills and will work closely with a global regulatory lead(s) to help develop and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Merck (Rahway, NJ)
- …Skills:** Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs ... **Job Description** The Associate Director, Regulatory Affairs , supports products in the...and collaboration skills and will work closely with a global regulatory lead(s) to help develop and… more
- Sanofi Group (Morristown, NJ)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. +… more
- Sanofi Group (Morristown, NJ)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated… more
- Sanofi Group (Morristown, NJ)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC , Biostatistics, GCO, in the execution ... will be a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will foster relationships with opinion leaders… more
- Merck (Rahway, NJ)
- **Job Description** Global Project and Alliance Management (GPAM) sits in the R&D organization at our Company. GPAM comprises several distinct groups, including ... Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and… more
- Sanofi Group (Morristown, NJ)
- …work with medical leads, data managers, statisticians, clinical supplies managers and regulatory affairs specialists, etc.. + ensure compliance with relevant ... + May be a core team member of the Global Project Team (GPT), representing and accountable for CSO...Collaborates upfront with CSCO, Demand and Supply Leader and CMC Leader in order to secure all aspects linked… more
