- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Global Regulatory Project Management ( Director , Global RPM) is a senior strategic leader responsible for ... NDA/BLA/MAA submissions and ensuring seamless cross-functional integration across regions. The Director , Global RPM proactively anticipates regulatory … more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating ... **Strategic Global Leadership** + Translate, implement, and advise on global regulatory strategies for development programs, ensuring alignment with business… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Senior Director , Regulatory Management, WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support of global marketing of company products ... the Sr Director Regulatory WWIPD, Regulatory strategies to enhance product quality design,...medical-related field + Successful track record with US and global regulatory bodies + Minimum of nine… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** **Senior Director , Global Supplier Quality ** Gilead Sciences, Inc. is ... is currently seeking a leader at the Senior Director level to lead a team of 10 -...Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC, and the Gilead Site Quality … more
- Bristol Myers Squibb (San Diego, CA)
- …. **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers ... Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality ...should be directed to Chat with Ripley. R1595190 : Director , Early Precision Medicine Regulatory Affairs **Company:**… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …solutions that enhance compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA, ... The Director , Global Product Quality ,...The Director , Global Product Quality , GMP Processes is...leadership role. + Deep understanding of GMP regulations and global regulatory requirements (eg, 21 CFR Parts… more
- Sumitomo Pharma (Sacramento, CA)
- … Regulatory 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 ...provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …business process design and governance practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, ... **Job Summary** The Associate Director , Quality Operations will lead initiatives...drive operational excellence, enhance risk management practices, and optimize global quality system processes across a … more
- BeOne Medicines (San Mateo, CA)
- …English native speaker is preferred + **Location:** US (remote). **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. ... **General** **Description:** The Regulatory Affairs Director Dx/CDx and Medical...plans. + Act as the representative of the US regulatory team at the global regulatory… more
- Amgen (Thousand Oaks, CA)
- …including ISO 13485, ISO 14971, and CLSI guidelines. + Design and implement global regulatory strategies that align with business goals and product development ... Join us and transform the lives of patients while transforming your career. ** Director , Regulatory Affairs - In-Vitro Diagnostics (IVD)** **What you will do**… more