- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …a timely manner + Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC /CP prduct development ... preparation of challenging communications + Manage the preparation for interaction with global regulatory authorities (eg, meetings, IR responses, inspections) +… more
- Insight Global (Rahway, NJ)
- …project management within the pharmaceutical or biotechnology industry, Strong knowledge of CMC processes, regulatory requirements, and quality standards in the ... Job Description We are seeking an experienced Program Manager to provide administrative support and oversee the strategic implementation of our CMC digitization… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the Senior Director, Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and assess all commercial ... Regulatory Affairs will stay abreast of changes in the global /US/Canadian regulatory framework, analyze proposed legislation/guidance that could impact the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC ,… more