- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... quality issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare documentation… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA)...within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …for assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more
- Sumitomo Pharma (Sacramento, CA)
- … Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function ... as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- GRAIL (Menlo Park, CA)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Regulatory Affairs will be responsible for developing, implementing, and advising North America (NA) ... line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders....candidates will have experience working as a lead in Regulatory Affairs with the FDA, and prior… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... products for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a...key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- The Associate Director of Regulatory ...+ Build professional network with key stakeholders outside of Global Regulatory Affairs to identify ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- BeOne Medicines (Emeryville, CA)
- …the Job:** + The individual should collaborate internally with Quality, Supply Chain, Regulatory Affairs and externally with CDMO to ensure timely and ... the manufacturing sites in domestic and international region is required. **BeOne Global Competencies:** When we exhibit our values of Patients First, Collaborative… more
- J&J Family of Companies (Irvine, CA)
- … Strategic Marketing (GSM), Health Economics and Market Access (HEMA), and Clinical Affairs (CA). Associate Medical Director , under limited supervision, in ... apply. We are searching for the best talent for ** Associate Medical Director , Cardiac Imaging.** **Role Purpose**...+ Partner with Clinical Research (and other partners, eg, Regulatory Affairs ) in the development and execution… more