- Ascendis Pharma (Palo Alto, CA)
- …Analyze, evaluate, interpret, and report clinical data + Anticipate and solve complex drug development problems + Contribute to regulatory strategy + Contribute ... 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
- Abbott (Temecula, CA)
- …other regulatory requirements. + Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating ... customers, contractors, and vendors. + Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,… more
- Abbott (Alameda, CA)
- …compliance, cost, and proactive improvements. * Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, ... of healthcare. As an individual contributor, the Quality Assurance and Regulatory Affairs (QARA) Project Manager combines knowledge of business objectives, quality… more
- Abbott (Pleasanton, CA)
- …compliance, cost, and efficiency improvements. + Comply with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, ... make sound design recommendations, in accordance with Company and regulatory requirements/guidance, and standards. This position provides leadership and mentoring… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. + Ensures adherence to regulatory requirements ... manner in line with the department and corporate goals and within regulatory and resource guidelines. **Job Responsibilities** + Provides ongoing medical monitoring… more
- AbbVie (Irvine, CA)
- …efforts focused on phase appropriate peptide drug substance and drug product development. + Experience developing global regulatory strategies including ... + The candidate will lead analytical teams associated with drug substance and drug product development and...authoring regulatory submissions, and responding to regulatory questions across global markets. + Lead across functions… more
- Amgen (Thousand Oaks, CA)
- …best practices that fit Amgen's business needs are effectively applied + Represents Drug Substance Technologies as a scientific, regulatory and technical expert ... drug applications, marketing authorization applications, and responses to regulatory questions + Well-recognized and established in the scientific community… more
- Abbott (Sylmar, CA)
- …other regulatory requirements. 6. Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating ... 3. Remains current on developments in the field of expertise, applicable regulatory requirements, and a comprehensive knowledge of Abbott's products. 4. Resolves… more
- Stanford Health Care (Palo Alto, CA)
- …staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, sample ... Administration, Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information,… more
- Abbott (Sylmar, CA)
- …other regulatory requirements. + Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating ... + Remains current on developments in field(s) of expertise, applicable regulatory requirements, and a general knowledge of the company's products, markets,… more