- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… 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 ... therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Parexel (Harrisburg, PA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- … 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
- Eurofins US Network (Lancaster, PA)
- …and products. **Job Description** **Role Overview** The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing Good Manufacturing ... This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal 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
- Kelly Services (Malvern, PA)
- …solution provider and business unit of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month + engagement at one of our Global clients in ... phase changes of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** + Accountable for… more
- Sanofi Group (Swiftwater, PA)
- …diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D ... support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration… more
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