- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and advocates for Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable for resourcing of personnel ... and budget for Global CNS Medical Strategy + Participates in the evaluation of potential in-licensing candidates + Helps establishes SOPs and sets standards to ensure that the medical strategy function operates effectively and efficiently Ensures compliance… more
- Lactalis American Group Inc. (Turlock, CA)
- …the Quality Systems Supervisor ensures compliance with industry standards and regulatory requirements, ultimately enhancing product quality and organizational ... + Keeping up to date with industry trends and regulatory changes to ensure the QMS remains effective and...+ Performs internal audits and leads external audits including regulatory compliance. + Performs management review of quality and… more
- ThermoFisher Scientific (San Diego, CA)
- …interfaces effectively with key internal directorates including Operations, Biometrics, Regulatory , Pharmacovigilance, and Global Product Development to ensure ... high EQ important + Thorough understanding of overall biologic/pharmaceutical product development process from pre-clinical through post-marketing, including all… more
- CoStar Realty Information, Inc. (Sunnyvale, CA)
- …and ensure documentation is up to date. + Collaborate with engineering and product teams to ensure hardware meets regulatory requirements before market entry. ... and Incoterms. + Liaise with customs brokers, freight forwarders, and regulatory bodies to resolve compliance issues. + Maintain internal compliance documentation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …(GSC) and other Gilead functions - eg, Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory , and ... and management for clinical development program(s), including management of investigational medicinal product (IMP) for assigned global trials. + Often in a matrix… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … Product Development System + Ensure R&D activities satisfy regulatory standards including documentation and reporting requirements. + Effectively collaborate and ... aspects-from concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance. This new role is ideal for someone who thrives in… more
- Amgen (Thousand Oaks, CA)
- …change the world! As part of Amgen's Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated **Senior Engineer** to provide ... Periodic shift work or on call work is required. **Key Responsibilities:** **New Product Introductions** + Leads or supports new product introductions and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and end of life activities. The Director will oversee the ... a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director of...needed + Support business export control (BEC) listing of product for release globally per RA requirements + Support… more
- Sumitomo Pharma (Sacramento, CA)
- …programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and ... of the cross-functional teams from preclinical experiments to the end of the product 's life cycle. + Clinical Trial Oversight: Develop and oversee clinical trial… more
- Bayer (Berkeley, CA)
- …process- and product -specific quality strategy; + Review and contribute to regulatory submissions, including INDs and BLAs; + Co-create regulatory roadmaps ... for Cell Therapy at Bayer is instrumental in providing strategic, scientific, and regulatory guidance for our late-stage cell therapy pipeline with a primary focus… more