- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… 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 ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Bristol Myers Squibb (Princeton, NJ)
- …in one or more key areas - Drug Development/ CMC /Pharmtox/ Biopharmaceutics/Clinical/Promotional. + Inter-dependent partnering skills, team-oriented and ability ... Paid Time Off + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ,… more
- Bristol Myers Squibb (Madison, NJ)
- …experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and ... Paid Time Off + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ,… 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 ... supply chain activities in preparation, commercialization, and launch of new products in development in North American market (US and Canada) related to planning, procurement, label and packaging development, distribution, importation, export, and vendor… 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 ... diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D… more
- Bristol Myers Squibb (Madison, NJ)
- …T he individual will provide technical expertise and leadership to Product CMC /Quality Teams to develop, implement, and manage the strategies for Quality to ... functions. + Supports the overall product quality strategy based on CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments.… more
- Bristol Myers Squibb (Princeton, NJ)
- …within [Disease Area] + Prioritizes, synthesizes, and pressure tests feedback from senior leadership on program direction/outputs and coaches GPLs in building this ... Development) and across the Enterprise (eg, Operations, GPS, Commercial) + Engages senior leaders and functional area stakeholders to ensure alignment of program… 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