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
$120 - $175 per hour
...onsite per week We are seeking a Senior Regulatory Submission Lead to support a critical BLA submission... ...regulatory documentation. Ensure clinical and biometrics outputs are incorporated... .... Manage submission documentation, QC, version control, and workflows within...RegulatoryHourly payContract work- ...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- Sequoia Hospital in Redwood City, CA seeks a Sr. Clinical Lab Scientist to perform the full scope of tests in the assigned lab section... ...or clinical lab setting. You will ensure quality control, regulatory compliance, and timely reporting of results, while maintaining...Regulatory
- 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
$211k - $264k
Revolution Medicines is a late-stage clinical oncology company developing novel... ...pathway.The Opportunity:The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving... ...functional development & regulatory submission activities for registrational oncology...RegulatoryFull timeWork experience placementLocal area$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- ...procedures, provides assistance on clinical research studies.... ...procedures. Assists with regulatory binders and QA/QC procedures. Assists with... ...Assists with study regulatory submissions. Writes consent forms.... ...perspectives and ideas, we choose to lead. All qualified applicants...RegulatoryFull time
$244k - $305k
Revolution Medicines is a late-stage clinical oncology company developing... ...Senior Director, Global CMC Lead. The Senior Director, Global... ...CMC cross functional teams, Regulatory, Quality, Clinical... ...execution for global regulatory submissions, including INDs, CTAs, NDAs/MAAs...RegulatoryFull timeLocal area- ...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
- ...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
$211k - $264k
Revolution Medicines is a late-stage clinical oncology company developing novel targeted... ...Nonclinical Development and Clinical Pharmacology (NDCP) Organization.As a member of the... ...function.Author technical reports and/or regulatory documents for major milestones of clinical...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
- ...Jobtailor, based in Palo Alto, CA, seeks an MD with clinical trials expertise to lead medical oversight for development programs. You will... ...communication and leadership are essential to advance regulatory submissions and study integrity. #J-18808-Ljbffr Jobleads-USRegulatory
$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$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- ...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
$160k - $170k
...and develop their skills.The Senior Clinical Trial Manager (Sr CTM) is responsible... ...Support central and site IRB/IEC and regulatory submissions, as needed.Accountable to assist sites... ...natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent...RegulatoryFull timeTemporary workWork experience placementWork at officeRemote workFlexible hours$72.69 - $80.25 per hour
...Lead Mammography TechnologistInspired by faith. Driven by innovation. Powered by humankindness... ...annually through more than 2,300 clinics, care sites and 158 hospital-based locations... ...radiologists and adhere to safety and regulatory standards for comprehensive breast health...RegulatoryRelocation package- ...Medicines in Redwood City is seeking a Senior Director of Clinical Data Management to lead data management operations for clinical trials. The... ...leadership and communication skills, and a deep understanding of regulatory requirements. This role focuses on strategic development...Regulatory
$95 - $117 per hour
...Clinical Trial Manager ~ Hybrid- On-site 3-4 days per... ...selected CROs and help lead cross-functional study.... ...Assist with IND/CTA submission preparation. Support... ...quality meets company and regulatory requirements. May perform... ...and conduct periodic QC reviews of the TMF to...RegulatoryFull timeContract workFor contractors3 days per week- ...Clinical Trial Assistant The Clinical Trial Assistant (CTA) provides... ...broad range of clinical and regulatory activities. The CTA will play... ...: Maintain, organize and QC Trial Master Files (TMF/eTMF)... ...reports and regulatory submissions Provide administrative support...RegulatoryWork at office
- ...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
- ...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
$298k - $350.6k
...antagonists. With advanced clinical trials in patients with hypercortisolism... ...will be responsible for leading the Medical Safety Physician... ...cross‑functional decisions Regulatory & Governance Oversee medical... ..., and regulatory safety submissions Support health authority...RegulatoryFull time$80k - $120k
...looking for a rigorous, hands-on Clinical Laboratory Scientist to run... ...-ready shape, tracking QC metrics, and producing traceable... ...records that will support our FDA submission. What You'll Do High-... ...monitoring visits, audits, and regulatory inspections of the laboratory...RegulatoryFull timeWeekend work$186k - $233k
...Director Clinical Operations Summit Therapeutics Inc. is a biopharmaceutical oncology company... ...as the cross‑functional study team lead for our clinical development program, responsible... ...operating within budget, timelines, regulatory, and quality standards. Responsibilities...RegulatoryFull time$244k - $305k
Revolution Medicines is a late-stage clinical oncology company developing... ...operational execution, and regulatory compliance to ensure data... ...responsibilities include leading and managing data management... ...requirements including submissions and data management systems....RegulatoryFull timeContract workLocal area- ...with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on the... ...as CDISC, 21 CFR Part 11, ICH, GCP guidelines, and other regulatory submissions to the NDA. Demonstrated ability to multi-task, prioritize...RegulatoryWork experience placement
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