- ThermoFisher Scientific (Carlsbad, CA)
- …safe or helping find cures for cancer. **Location/Division Specific Information** Within the Regulatory and Clinical Affairs division, we focus on ensuring that ... in vitro diagnostics adhere to Good Clinical Practice (GCP) and relevant regulatory standards (national and international). We also ensure that FDA submissions are… more
- Merck (San Diego, CA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents ... regulatory strategies, processes, standards, practices, efficiencies and capabilities. + Represents Regulatory Affairs and may serve as Regional Lead or… more
- BeOne Medicines (San Mateo, CA)
- …levels, including BeOne's Senior Management. This role blends deep expertise in regulatory affairs with best-in-class project management skills to ensure timely, ... mitigation plans, both internally and with external partners. + Collaborate with Regulatory Affairs , Clinical, CMC, Quality, Safety, and Commercial functions to… more
- Stanford University (Stanford, CA)
- …impact. We are looking for someone who already has a strong foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working ... certification not required, but some previous coursework or prior jobs in regulatory affairs is expected. This position can offer a hybrid work arrangement,… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- BeOne Medicines (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... + Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with… more
- Sumitomo Pharma (Sacramento, CA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... the Regulatory reviewer for assigned products. This position is responsible...eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of promotional material review… more
- BeOne Medicines (San Mateo, CA)
- …of the patient voice across all levels of decision-making. + Ensure patient affairs initiatives comply with global, regional, regulatory requirements and ethical ... communities. **Cross-Functional Collaboration** + Partner closely with R&D, Medical Affairs , Clinical Development, Regulatory , Global Commercial, Government … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Medical Affairs , US Commercial, US Government Affairs and Policy, US Public Affairs , US Regulatory , and US legal and compliance + Represent US data gaps ... professionals and advocates, ensuring high-quality deliverables such as medical affairs resources, medical presentations at conferences, advisory boards and medical… more