- Sumitomo Pharma (Trenton, NJ)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- Sumitomo Pharma (Trenton, NJ)
- …Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with ... Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Penn Medicine (Cherry Hill, NJ)
- …: + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... to emergency/code situations. + CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Somers Point, NJ)
- … Regulatory Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... geriatric. Clinical Care Associates (CCA) CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads… more
- System One (Piscataway, NJ)
- …cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays + Document results in compliance with GMP, ICH, and FDA standards + Author and ... molecule and biosimilar products. Candidates must bring strong GMP and regulatory knowledge, with expertise in protein chemistry and analytical troubleshooting. If… more
- Astrix Technology (New Brunswick, NJ)
- … compliance with cGMP regulations, quality systems, and applicable ICH/ regulatory guidelines. + Participate in the investigation and documentation of ... regulatory submissions and data packages for interactions with regulatory agencies (eg, FDA ). This job description is a complete list of all desired… more
- Penn Medicine (Somers Point, NJ)
- …Regulatory + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... + Clinical Care Associates (CCA) MAs - if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Woodbury Heights, NJ)
- …: + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... to emergency/code situations. + CCA CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support,… more
- Cardinal Health (Trenton, NJ)
- …is seeking a driven and skilled attorney with expertise in healthcare regulatory compliance , including third party billing and reimbursement. The Assistant ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more