- BeOne Medicines (Emeryville, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- Abbott (Alameda, CA)
- …make recommendations on future actions. + Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, ... glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work on-site at… more
- Abbott (Santa Clara, CA)
- …other regulatory requirements. + Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company ... place to work for diversity, working mothers, female executives, and scientists This ** Regulatory Affairs Specialist II** will work on-site at our Santa Clara, CA or… more
- Sumitomo Pharma (Sacramento, CA)
- …a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/she...Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA. + Serve as internal… more
- Ascendis Pharma (Palo Alto, CA)
- …of CDISC standards, including SDTM and ADaM. + Understanding of the clinical drug development process and regulatory requirements. + Proficiency in SAS ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- Astrix Technology (Los Angeles, CA)
- ** Regulatory Affairs Specialist (Global)** Regulatory Affairs Los Angeles County, CA, US Pay Rate Low: 65 | Pay Rate High: 80 + Added - 15/10/2024 Apply for Job ... innovative clients who specializes in the Nutraceutical space is seeking a Sr. Regulatory Affairs Specialist (Global) to help expand portfolio. This is a great… more
- Astrix Technology (Anaheim, CA)
- …quality systems aligned with federal cGMP regulations for cosmetics and OTC drug products + Interpret and integrate regulatory requirements into manufacturing ... actions + Respond to FDA observations and ensure full regulatory compliance + Maintain the OTC Master Drug... regulatory compliance + Maintain the OTC Master Drug List + Collaborate with suppliers, customers, and … more
- Merck (South San Francisco, CA)
- …clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and ... Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and… more
- University of Southern California (Los Angeles, CA)
- …spans the entire spectrum of pharmaceutical development and clinical care - from drug discovery to regulatory approaches that promote safety and innovation, from ... delivery of contemporary patient care services to evaluating the impact of care provision on patient outcomes and costs. The school's dynamic faculty is involved in all levels of pharmacy education: from undergraduate majors to multiple MS and PhD graduate… more
- Abbott (Pleasanton, CA)
- …and professional work environment. + Comply with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, ... Management System compliance to internal policies, applicable standards and external regulatory requirements. **What You'll Work On** + The incumbent defines and… more
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