- Bristol Myers Squibb (San Diego, CA)
- …+ Proven track record in managing complex clinical programs leading to regulatory submissions + Deep understanding of Biology, targets and translational ... trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for specific disease /… more
- Sumitomo Pharma (Sacramento, CA)
- …support company objectives. + Champion regulatory and technical documents for regulatory submissions in support of manufacturing and serve as subject matter ... Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply...expert in regulatory interactions. + Maintain a high level of safety,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Analyze and interpret clinical trial data; contribute to clinical study reports, regulatory submissions , and publications. + Collaborate with external experts, ... key role in shaping clinical strategy, collaborating cross-functionally with research, regulatory , safety, and commercial teams to advance innovative therapies that… more
- AbbVie (Irvine, CA)
- …of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- US Tech Solutions (San Bruno, CA)
- …as providing training and mentoring to engineers to ensure audit readiness and regulatory submissions . + Support bringing novel medical devices from concept to ... Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified Bodies, etc.), and regulatory audits.… more
- Sumitomo Pharma (Sacramento, CA)
- …documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required. . Participates ... and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies. + Participates… more
- Stanford University (Stanford, CA)
- …case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. ... to manage data, enroll and follow patients on trial and assist with regulatory and financial requirements of the trials. We are seeking candidates with excellent… more
- Bayer (Berkeley, CA)
- …science-driven, process- and product-specific quality strategy; + Review and contribute to regulatory submissions , including INDs and BLAs; + Co-create ... for Cell Therapy at Bayer is instrumental in providing strategic, scientific, and regulatory guidance for our late-stage cell therapy pipeline with a primary focus… more
- Caldera Medical (Westlake Village, CA)
- …complaint evaluations, including medical device reporting (MDR) or equivalent regulatory submissions . * Collaborate with cross-functional teams (Quality, ... activities to ensure compliance with FDA, ISO, and other applicable regulatory requirements. The ideal candidate will have strong analytical skills, experience… more
- Stanford University (Stanford, CA)
- …case report forms for completion and accuracy with source documents. Prepare regulatory submissions , and ensure institutional Review Board renewals are ... + Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. + Determine eligibility… more