- BeOne Medicines (Emeryville, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Gilead Sciences, Inc. (Foster City, CA)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory ... Operations & Submissions** Oversee the drafting, review, and approval of CMC sections for regulatory filings. Provide leadership for agency interactions,… more
- Sumitomo Pharma (Sacramento, CA)
- …dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part ... strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs… more
- AbbVie (Irvine, CA)
- …join us as a Group Leader based in Irvine, CA reporting to the Director , PDS&T Toxins. Responsibilities: + Manage the protein characterization group by working with ... for a comprehensive understanding of the product structure-function relationship. + Lead CMC analytical development with in-depth knowledge of a broad range of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Job Description** **Head of Technical Development Data & Digital Team (Senior Director )** We are seeking a highly motivated individual to join the Technical ... Development Strategy and Operations team as **Senior Director of Data & Digital Team** . The successful...and partner closely with Technical Development leadership, IT, Manufacturing, CMC Regulatory and the broader Gilead digital ecosystem. **Key… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …aspirations. Join Kite and help create more tomorrows. **Job Description** **Executive Director , Global Supply Chain, Head of Planning** Everyone at Kite is grounded ... in our mission! We are looking for an Executive Director of Global Supply Chain, Head of Planning reporting...Packaging & Labeling operations. Serves as advocate to shape CMC strategy and product decisions, deliver TechOps readiness for… more
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. ** Director , Regulatory Affairs - In-Vitro Diagnostics (IVD)** **What you will do** Let's ... do this. Let's change the world. Amgen is seeking a Director of Regulatory Affairs to work in their Thousand Oaks, CA location. The Regulatory Affairs division… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for small-molecule ... site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: Foster ... City_** **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Global Regulatory Project Management ( Director , Global RPM) is a senior strategic leader responsible for supporting, ... submissions and ensuring seamless cross-functional integration across regions. The Director , Global RPM proactively anticipates regulatory challenges, influences decisions,… more