- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …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
- Sanofi Group (Morristown, NJ)
- …Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead, participates in project ... **Job Title:** Sr . Non-Clinical Biostatistician **Location:** Swiftwater, PA **About the...bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …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
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Sr Director, Global Regulatory Strategy, Neuroscience** + Will be a key ... your application should be directed to Chat with Ripley. R1596806 : Senior Director, Global Regulatory Lead Neuroscience **Company:** Bristol-Myers Squibb **Req… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors...of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP… more
- Bristol Myers Squibb (Madison, NJ)
- …program goals in compliance with GCP, ICH and other global regulatory requirements + Provides comprehensive strategic leadership for 2,100+ multi-site organization ... experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and… more
- Bristol Myers Squibb (Madison, NJ)
- … CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments. + Provides technical quality expertise and compliance oversight ... the commercial program (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.The PQL must… more
- Bristol Myers Squibb (Princeton, NJ)
- …with drug development functions (including Strategy & Portfolio Management, Global Regulatory & Safety, and Global Development Operations), and other functions ... within [Disease Area] + Prioritizes, synthesizes, and pressure tests feedback from senior leadership on program direction/outputs and coaches GPLs in building this… more
- Integra LifeSciences (Plainsboro, NJ)
- …through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend ... Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality… more