- BeOne Medicines (Emeryville, CA)
- …ensure robust study design, insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK modeling, including ... . Ensure high-quality, compliant, and timely delivery of statistical components for regulatory submissions (eg, INDs, NDAs, BLAs, and global equivalents). .… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...database configuration updates, submission rules management and testing with regulatory authorities. + Serve as a subject matter expert… more
- Element Materials Technology (Morgan Hill, CA)
- …who canapply engineering problem solving skills to evaluate wireless devices for global Regulatory compliance involving EMC/RF Testing for wireless consumer ... technologies to determine FCC (US) and ISED (Canada), and other global regulatory body compliance. Salary: $38-45/hr **Responsibilities** + Performs… more
- Sumitomo Pharma (Sacramento, CA)
- …of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …PSO provide guidance to successfully deliver best-in-class secure products, consistent with global regulatory requirements over the lifecycle. This role works in ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...partnership with R&D, Enterprise Security, Quality, Regulatory Affairs, and leaders at corporate, regional, and business-unit… more
- Western Digital (Sacramento, CA)
- …updates to senior leadership and key stakeholders. + Ensure compliance with global regulatory and sustainability standards throughout the supply chain lifecycle. ... **Company Description** At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once… more
- Medtronic (Irvine, CA)
- …to relevant industry standards and compliance regulations (eg ISO 13485 and global regulatory requirements). **Must Have: Minimum Requirements** _To be ... differently to solve problems, make progress, and deliver meaningful innovations. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality… more
- Merck (San Francisco, CA)
- …coaching/guidance to individual contributors + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics and ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an...authoring regulatory documents (INDs, CSRs, CTDs) **Required Experience:** + (a… more
- Ascendis Pharma (Palo Alto, CA)
- …validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA ... safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global ...applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to travel up to… more
- Google (Mountain View, CA)
- …requirements, enhancing controls, increasing data processing frequency, and ensuring global regulatory compliance. You will drive programmatic transformation ... Lead Google's corporate environmental metrics accounting program, ensuring compliance with global regulatory , voluntary, and internal disclosure requirements. +… more