- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate...(eg, GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …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
- Kelly Services (Malvern, PA)
- …other cross-functional departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead ... ** Project Coordinator** Kelly Services is currently seeking a...of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month + engagement at one… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … 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...Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
- ICON Clinical Research (Blue Bell, PA)
- …medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). Vendor ... Clinical Drug Supply Manager ICON plc is a world-leading healthcare intelligence...needed. Supports inspection team in preparation for and during regulatory agency inspection. Study Team Interaction + Represents Clinical… more
- Wells Fargo (Wilmington, DE)
- …Network Mandates and Rules on Credit Cards. This individual will be a program manager , overseeing all Network rule and mandated changes that need to be implemented ... to a cross-functional team using business expertise. + Perform General Project /Program Management including managing contact list, tracking responses from Business… more