- Abeona (Cleveland, OH)
- …achieve commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs , CMC , Biometrics, and other ... We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic...working with technical operations or similar groups and has CMC experience within the pharmaceutical or biotech industry. The… 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
- J&J Family of Companies (Raritan, NJ)
- …in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs , CMC Regulatory Affairs , Product Artwork, and ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...& Johnson Innovative Medicine R&D is recruiting for a Manager , Global Labeling Operations. This position is a hybrid… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …Society for Quality (ASQ) as a Certified Quality Auditor (CQA) and/or from the Regulatory Affairs Professional Society (RAPS) as a Regulatory Affairs ... guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- ThermoFisher Scientific (Wilmington, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more
- ThermoFisher Scientific (Wilmington, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more