- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- Provide CMC regulatory strategy input and expertise...and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance ... technology, drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Sumitomo Pharma (Raleigh, NC)
- …clinical supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA ... 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 PDM to… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- Sumitomo Pharma (Raleigh, NC)
- …**Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, ... closely with program management, clinical development, PV, Biostat/Data Management, CMC , Biomarker/Translational Research, preclinical DMPK, etc to formulate clinical… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager . Primary responsibilities for this position will be: perform QC analysis in ... and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during...the Revenue and Capex Budget as per spent analysis project . + Execute and maintain quality system controls to… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …compound development strategy to approved budgets and timelines in close collaboration with the Project Manager (PM) assigned from the PMO. + The GPL will ensure ... Infectious Disease or Intensive Care) . GPLs will provide strategic project leadership and oversight within a cross-functional, highly matrixed, global program… more