- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC ... skills are essential for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day might… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... technology, drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development… more
- Sumitomo Pharma (Albany, NY)
- …clinical supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA ... highly motivated, and experienced individual for the position of ** Senior Manager, Clinical Supply Chain** . The Senior...and/or local regulations. + Collaborate closely with Clinical Operations, CMC , Regulatory Affairs, QA, and PDM to… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …for writing and reviewing documents that support Manufacturing, Quality Control, and CMC Regulatory departments. As a Sr. Process Controls & Validation ... position. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are… more