- Cytel (Sacramento, CA)
- …all data related deliverables, especially in support of key decision points and regulatory submissions . + Works cross-functionally to ensure the quality of the ... + **Quality & Compliance:** + Ensure all processes and deliverables meet regulatory requirements and internal quality standards. + Support audit readiness and… more
- IQVIA (Carlsbad, CA)
- …issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form ... Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. * Create and maintain appropriate documentation regarding site management,… more
- Gilead Sciences, Inc. (La Verne, CA)
- …identification and resolution of non-conformances/deviations. . Assist in preparation of regulatory submissions and presents validation in respective SME areas ... to regulatory authorities during regulatory inspections. . Manage contractors performing system qualifications, ensure the quality of completed deliverables. .… more
- BeOne Medicines (Emeryville, CA)
- …Initiated Trials and Research, which may lead to clinical data needed for regulatory submissions , go-no go, and publications. + Directs and manages ... and non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program management,… more
- Boehringer Ingelheim (Fremont, CA)
- …function at Boehringer Ingelheim Fremont (eg, prepares documentation supporting regulatory submissions , actively participates in site readiness activities ... notifications, process changes at the CMO) potentially impacting product quality or regulatory compliance per the applicable procedure. + Acts as a subject matter… more
- Bristol Myers Squibb (San Diego, CA)
- …+ Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed ... activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream ... processing. + Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with… more
- Terumo Neuro (Aliso Viejo, CA)
- …clinical evaluation reports, clinical study reports, literature review, risk management, regulatory submissions , questions from regulatory authorities, ... and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise to provide input to study… more
- Ascendis Pharma (Palo Alto, CA)
- …validate tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions . + Support statisticians with planned and ad hoc ... taking responsibility for all programming deliverables from study start through regulatory submission. In addition, this person will support the development and… more
- Deloitte (San Jose, CA)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more