- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Sumitomo Pharma (Columbus, OH)
- …to clinical supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs , Quality Assurance, Clinical Operations, and ... motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager...and/or local regulations. + Collaborate closely with Clinical Operations, CMC , Regulatory Affairs , QA, and… more