- Gilead Sciences, Inc. (Foster City, CA)
- …key role in shaping clinical strategy, collaborating cross-functionally with research, regulatory , safety, and commercial teams to advance innovative therapies that ... of clinical trial protocols for inflammation programs, ensuring scientific rigor and regulatory compliance. + Serve as the clinical lead on cross-functional study… more
- Abbott (San Diego, CA)
- …cybersecurity into the product lifecycle** , ensuring our devices meet regulatory requirements and protect patient safety. **What You'll Work On** You'll ... work will support threat modeling, risk assessments, vulnerability management, and regulatory compliance, helping ensure our products are secure and resilient. +… more
- Amgen (Thousand Oaks, CA)
- …process technology transfer and other technical documents. **Process Validation & Regulatory Support** + Development of validation plans and supports execution of ... + Ensure site's process validation business process adheres to global regulatory agency standards, Amgen's quality requirements, other site policies and procedures,… more
- American Water (Sacramento, CA)
- …compliance with applicable local, state and federal laws and regulations that create regulatory risks and obligations for the State. The role is also responsible for ... laws and regulations that impact operations. * Review tariffs and regulatory orders for compliance requirements and incorporate into OCP. _ *Knowledge/Skills*_… more
- Element Materials Technology (Morgan Hill, CA)
- …products. The successful candidate will play a key leadership role, leveraging regulatory experience to guide technical teams, ensure regulatory alignment, and ... certification services for wireless products + Ensure compliance with international regulatory standards, including FCC, CE (RED/EMCD), IC, and other global… more
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead development,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …are provisioned for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the strategic leader of ... for the operation and managing resources to achieve policy, legislative, regulatory , and reputational goals that support core enterprise and therapeutic objectives.… more
- US Tech Solutions (San Bruno, CA)
- …Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified Bodies, etc.), and regulatory audits. ... providing training and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release,… more
- BeOne Medicines (San Mateo, CA)
- …attorney to provide legal support, counseling, and strategic guidance on commercial and regulatory matters for in North America. This role will be the lead product ... The successful candidate will have 8+ years of commercial and regulatory legal experience representing biotechnology/pharmaceutical companies in the United States… more
- BeOne Medicines (Emeryville, CA)
- …development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs, and Clinical Development to ensure robust study design, ... insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK modeling, including non-compartmental and population PK… more