Clinical Pharmacology QC Lead: Regulatory Submissions
Planet Pharma
A leading pharmaceutical company in Redwood City is seeking a QC Lead to conduct quality control reviews of clinical pharmacology submissions. The ideal candidate will verify scientific accuracy, ensure cross-document consistency, and prepare high-quality documentation compliant with FDA/EMA standards. Candidates should possess an advanced degree in life sciences and have strong experience with NDA submissions and regulatory documents. This role offers the opportunity for full-time or part-time hours on a 6-month contract basis with competitive compensation. #J-18808-Ljbffr Planet Pharma
- ...or Part-Time hours Compensation: Open/Competitive contract rates The Role The QC Lead performs rigorous quality control reviews of clinical pharmacology submission documents and regulatory responses. Responsibilities include ensuring: Scientific Accuracy: Verifying...RegulatoryPermanent employmentFull timeContract workPart timeRemote work
$144k - $180k
...portfolio of cutting‑edge molecular diagnostic tests. As a Lead Biostatistician, you will leverage your strong applied... ...to oversee the design, analysis, and interpretation of clinical trials for regulatory submissions to support our oncology portfolio. Primary...RegulatoryImmediate startWorldwide- Stanford University is seeking a Clinical Research Coordinator Associate to oversee the management and implementation... ...at Stanford Hospital and Clinics. You will ensure regulatory compliance, assist with IRB submissions, consent processes, data collection, and CRF...Regulatory
- ...Perioperative and Pain Medicine at Stanford Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support... .... The role emphasizes HRPP/IRB coordination, regulatory submissions, and ongoing compliance across drugs, devices, and AI-...Regulatory
- Senior Clinical Lab Scientist at Dignity Health - Sequoia Hospital in Redwood City, CA will perform the full scope of tests in the assigned... ...CLS licensure and applying strict quality control and regulatory standards within a hospital setting. Candidate should have extensive...Regulatory
$153k - $178k
...various characterization testing activities that enable regulatory filings. This role will serve as the primary... ...laboratories to enable operation as a Phase I/II early clinical release and stability testing QC laboratory. This requires an individual with a solid understanding...RegulatoryWork experience placement$201k - $251k
Revolution Medicines is a late-stage clinical oncology company developing novel... ...pathway.The Opportunity:The Director of Regulatory Affairs (US Filing Lead) is accountable for driving... ...functional development & regulatory submission activities for registrational oncology...RegulatoryFull timeWork experience placementLocal area- Clinical Trial Associate - Contractor, Hybrid in Office... ...professionals, leading academic institutions... ...trials, adherence to regulatory guidelines, and the collection... ...including regulatory submissions, ethics committee approvals... ...through routine QC Responsible for sample...RegulatoryFull timeFor contractorsWork at officeWork from home
$244k - $305k
Revolution Medicines is a late-stage clinical oncology company developing novel targeted... ...:The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory... ...for cross-functional teams.Regulatory Submission LeadershipProvide strategic oversight...RegulatoryFull timeLocal area- ...Position: Clinical Research Associate (CRA) Location: Redwood City, CA Length: 6+ Month Contract... ...batch exports Quality Control (QC) metrics Identify documentation issues and... ...compliance with study protocols, GCP, and regulatory requirements. Collaborate with cross-functional...RegulatoryContract workInterim role
- ...experienced Director/Sr. Director of Clinical Pharmacology to lead the design and execution of PK/PD... ...The role requires collaboration with regulatory, translational research, and clinical... ...efficacy evaluations, and regulatory submissions while ensuring GCP/ICH compliance...Regulatory
- ...Prospectors in Redwood City, CA is seeking a Clinical Research Associate (CRA) with hands-on... ...adherence to study protocols, GCP, and regulatory requirements. You will conduct interim monitoring... ...of custody records, lab exports, and QC metrics, and collaborate with cross-...RegulatoryInterim role
- Stanford University in Palo Alto is seeking an experienced Clinical Research Coordinator 2 to support study start-up activities across... ...start-up, manage budgets, provide metrics, and ensure regulatory approvals under supervision. The role requires strong organizational...Regulatory
- ...biopharmaceutical client. You will lead CMC development from PCC nomination through IND submission, coordinating timelines, budgets, and... ...ability to drive CDMO partnerships, regulatory compliance, and manufacturing readiness for clinical #J-18808-Ljbffr Enigma SearchRegulatory
- Digital Prospectors seeks a Clinical Laboratory Scientist for 2nd shift in Redwood City, CA. The role involves performing... ...including next-generation DNA sequencing, with QA/QC responsibilities and strict regulatory compliance. The position is onsite with a 2:30-11pm schedule...RegulatoryContract workAfternoon shift
$100.03 - $132.51 per hour
Stanford Health Care is seeking a Lead APP (NP/PA) for ENT Surgery to provide supervision and management... ...practice providers. Key responsibilities include clinical oversight, administration, and compliance with regulatory issues. The ideal candidate has a Master's or...RegulatoryHourly payFull time- ...Director to support oncology trial execution and clinical development planning. This role will involve leading scientific discussions, ensuring medical oversight... ...will design studies, contribute to protocols and regulatory documents, manage budgets, and collaborate with...Regulatory
- Adicet Bio, Inc. is a clinical stage biotechnology company focusing on allogeneic gamma delta T cell... ...autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategy and submissions to accelerate clinical and product development...RegulatoryWork at office3 days per week
- Stanford Medicine's Department of Anesthesiology, Perioperative and Pain Medicine seeks a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support across a diverse clinical research portfolio. The role guides teams through HRPP/IRB processes and...Regulatory
- Stanford University’s Department of Neurology seeks a Clinical Research Coordinator II to conduct clinical research and manage progressively... ...with investigators and sponsors to monitor safety, ensure regulatory compliance, and support study budgets and invoicing, aligning...Regulatory
- ...Assurance Operations to build and lead the QA Operations team in Redwood... ...will ensure cGMP compliance for clinical manufacturing, manage disposition... ...with Manufacturing, Facilities, QC, and Regulatory to support regulatory submissions. You will report to the VP of Quality...Regulatory
- ...Assurance Operations to build and lead the QA Ops team and ensure cGxP compliance across clinical and regulatory activities. The role partners... ...Manufacturing, Facilities, QC, Regulatory, and other... ...improvement and supporting regulatory submissions and audits. Strong leadership...Regulatory
$229k - $268k
...Humankind!Vaxcyte is a clinical-stage vaccine innovation... ...to protect humankind.*LEAD WITH HEART: Everyone leads... ...compliance with global regulatory guidelines and... ...be the QA oversight of QC activities associated with... ...support of regulatory submissions.Take part in audit preparations...RegulatoryContract work- ...Team Leader Allakos Inc. is a clinical-stage company developing... ...technical, business, quality, regulatory representatives who also enjoys... ...critical activities. Your Role: Lead a cross-functional CMC team... ...CMC elements for regulatory submissions and consultations. Drive the...Regulatory
$226.19k - $292.71k
...DescriptionAs a Director within the Clinical Pharmacology Group at Gilead, you will have significant... ...and responsibilities will include:Leading clinical pharmacology studies of the... ..., analysis plans, study reports and regulatory submissions Developing high quality clinical...RegulatoryFull timeFor contractorsLocal area- Stanford University is seeking a Clinical Research Coordinator for the Otolaryngology -... ...recruitment, data collection, budgeting, and regulatory compliance in a fast-paced research... ..., supervise staff, coordinate IRB submissions, and collaborate with principal investigators...RegulatoryFixed term contract
$93 - $103 per hour
.../ Director / Sr. Director, Clinical Pharmacology Pay Rate: $93 - $103 per hour... ...candidates. This role will lead the design and execution of... ...with clinical development, regulatory affairs, and translational... ...trials through regulatory submission. This role requires working...RegulatoryHourly pay$160k - $170k
...grow and develop their skills.The Sr. Clinical Trial Manager (Sr CTM) is responsible... ...Support central and site IRB/IEC and regulatory submissions, as needed.Accountable to assist... ...natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent...RegulatoryFull timeTemporary workWork experience placementWork at officeRemote workFlexible hours$63 - $87 per hour
...DescriptionGuardant Health is a leading precision oncology company... ...Twitter) and Facebook. As a Senior Clinical Laboratory Scientist, you are... ...during testingCarry out QC/QA activities as part of the... ...policies, ethical standards, and regulatory requirements to improve the...RegulatoryFull timeWork at officeLocal areaWork from homeFlexible hoursShift work- ...looking for an Associate Director, Clinical Pharmacology based in our Foster City, CA office... ...assigned disease or therapeutic area.Leads and manages design and conduct of clinical... ...authors documents for clinical and regulatory submissions.Presents project updates and other...RegulatoryFull timeFor contractorsWork at officeLocal areaFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Clinical Pharmacology QC Lead: Regulatory Submissions. Be the first to apply!
- clinical lead Redwood City, CA
- clinical research lead Redwood City, CA
- clinical trial lead Redwood City, CA
- regulatory scientist Redwood City, CA
- regulatory cmc Redwood City, CA
- clinical research regulatory Redwood City, CA
- food regulatory Redwood City, CA
- regulatory Redwood City, CA
- regulatory engineer Redwood City, CA
- regulatory executive Redwood City, CA

