- 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
- ManpowerGroup (Foster City, CA)
- …Project Coordinator, you will be an integral part of the Regulatory Compliance department supporting vehicle registration, permitting, and ongoing compliance ... for deployment. + Support internal audits, external inquiries, and regulatory inspections by maintaining comprehensive documentation and traceability of filings.… more
- Gilead Sciences, Inc. (Foster City, CA)
- … agencies. ** Regulatory Intelligence Project (25%)** + Assess the impact of regulatory guidelines from the US Food and Drug Administration (FDA), European ... Opportunities** + Engage in cross-functional collaboration with Development, International Regulatory Affairs, and other stakeholders to understand research priorities.… more
- Bristol Myers Squibb (San Diego, CA)
- …the global leader in radiopharmaceuticals. **Job Description** The Assoc. Director, IT Regulatory , Clinical and Enterprise Systems is an integral part of bringing ... RayzeBio's innovative drug products to patients in need. In this role,...processes to achieve commercialization objectives across the Clinical Operations, Regulatory , Planning and Enterprise Systems. The role will ensure… more
- Amgen (Thousand Oaks, CA)
- …product teams that include partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain. The ... related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements. + Strong understanding of drug substance and … more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …prior regulatory experience. + Advanced knowledge of Food and Drug Administration (FDA) regulations and International Conference of Harmonisation (ICH) and Good ... That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with oversight and governance of … more
- Oracle (Sacramento, CA)
- …to drive growth across **Commercial, Real-World Evidence (RWE), Clinical, Regulatory , and Safety research services** within pharmaceutical and biotechnology ... clients, navigating stakeholder ecosystems across Commercial, Medical, Clinical Development, Regulatory , Safety, and HEOR functions. **Responsibilities** **Key Responsibilities** **Business… more
- Gilead Sciences, Inc. (Foster City, CA)
- …seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs, Quality, Technical Development, and Manufacturing stakeholders to align ... or a related scientific discipline is strongly preferred. + Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives.… more
- Parexel (Sacramento, CA)
- …study reports, Investigators Brochures, and other related documents + Contribute to regulatory agency submissions (Investigational new drug applications, new ... while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient… 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