- Boehringer Ingelheim (Duluth, GA)
- …or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic and operational...initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving… more
- BMO Financial Group (New York, NY)
- …reserve calculation for BMO Chicago Branch, and as needed assist in CMC regulatory reporting and other financial/statutory reporting matters. Works closely ... Member of the broker/dealer regulatory reporting team who will be responsible for...customers reach theirs. From in-depth training and coaching, to manager support and network-building opportunities, we'll help you gain… more
- Teva Pharmaceuticals (Weston, FL)
- …affect program delivery or quality. Work with all key departments-clinical, commercial, regulatory , CMC , operations, IP, TPO-to ensure program quality and ... Senior Manager R&D Global Program Leadership Date: Nov 13,...program's Integrated Development Plan (IDP), coordinating commercial, clinical, and CMC leadership across strategic plans for product, clinical, and… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... The Senior Manager , Global Product Quality - Biologics is responsible...in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role… more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... improvements, and support method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring… more
- ThermoFisher Scientific (Wilmington, NC)
- …to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical operational and ... may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; eg process… more
- Gilead Sciences, Inc. (Foster City, CA)
- …as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Regulatory Chemistry, Manufacturing and Controls (RA CMC ),to identify ... oversight forassigned GileadCXO partners/sites. + Assure CXOs meet Gilead's quality, regulatory and compliance standards, to ensure a sustainable delivery of quality… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . The role of the ** Manager , Trial Supply Management** is to create and maintain supply strategies ... for all investigational product based on the scientific and regulatory confines of the drug's development with minimal supervision. Working independently, they will… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted supply of ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the supply chain activities ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more