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
$165k - $230k
...translational, nonclinical, clinical, and regulatory work. We are building a... ...Methodology to lead how regulated‑pharma judgment... ...Nonclinical / preclinical pharmacology or toxicology with submission‑level engagement —... .../ acceptance criteria / QC design for automated systems...RegulatoryFull time- 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
- ...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... ...The Opportunity: The Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation... ...development & regulatory submission activities for registrational oncology...RegulatoryFull timeWork experience placementLocal area$160k - $185k
...therapeutics toward the clinic. Key Responsibilities Timeline... ...) In Vivo Pharmacology Formulation and CMC Toxicology... ...other documents required for regulatory purposes are completed and QC’d on time. Global CRO... ...development process (through lead optimization, candidate...RegulatoryContract work$195.67k - $253.22k
...searching for an Associate Director, Clinical Pharmacology based in Foster City, CA or... ...assigned disease or therapeutic area. Lead and manage the design and conduct of... ...and author documents for clinical and regulatory submissions. Present project updates and other key...RegulatoryFlexible hours$23.15 - $31.16 per hour
...making a difference in people’s lives. The Lead Medical Assistant is an allied health... ...professional who works under the guidance of the clinical and administrative leadership of a... ...and oversight for compliance and regulatory matters, referring issues to the Practice...RegulatoryHourly payWork at officeShift work- ...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
$186k - $233k
...Director Clinical Operations Summit Therapeutics Inc. is a biopharmaceutical oncology... ...serve as the cross‑functional study team lead for our clinical development program, responsible... ...operating within budget, timelines, regulatory, and quality standards....RegulatoryFull time$47.64 - $59.57 per hour
...POSITION SUMMARY The Clinical Laboratory Scientist analyzes specimens and maintains equipment... ...on time Act as the go‑to person when lead/supervisor is not available Receive... ...current practices Ensure compliance with regulatory agency requirements through proper documentation...RegulatoryWeekend work$50 - $60 per hour
...Scientist/Associate Director, Clinical Biomarkers Principal... ...Clinical Biomarkers will be the lead in the execution of scientific... ...program development plans and regulatory strategies. Generate appropriate... ...Scientist / Director, Clinical Pharmacology San Francisco Bay Area $50.00...RegulatoryFull timeRelocation package- ...Company, is a mission-driven clinical-stage company that aims to... ..., reproducibility, and regulatory compliance. Lead and execute purification development... ...‑functionally (AD, USP, QC, RA) to ensure seamless... ...authoring sections of regulatory submissions, including IND, or BLA...RegulatoryContract workWork at office
$285k - $340k
GondolaBio is a clinical‑stage biopharmaceutical company... ...DMPK and clinical pharmacology scientist with specialized... ...workstation, and regulatory meetings, and you are... ...strategy: Serve as the lead DMPK/Clinical Pharmacology... ...for regulatory submissions. Biomarker and target...RegulatoryFlexible hours- BioRobotics is looking for a Principal Regulatory Affairs Specialist to provide regulatory leadership from product development through... ...be responsible for coordinating and preparing regulatory submissions, ensuring compliance with FDA and international regulations....Regulatory
- ...areas. Ensure testing, product QC, and operational support... ...instrumentation and testing methods. Regulatory & Quality Oversight Ensure... ...a team including licensed Clinical Laboratory Scientists, supervisors... ...standards. Proven ability to lead process improvements, manage...RegulatoryFull timeContract workDay shift
- ...Global Patient Safety Quality and Compliance (Pharmacovigilance) to lead the PV-QMS program and ensure global regulatory compliance across FDA, EMA, and other authorities. The role collaborates across Clinical Operations, Regulatory Affairs, and Quality Assurance to...Regulatory
- ...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
$211k - $264k
Revolution Medicines is seeking a Director of Regulatory Affairs to oversee NDA/MAA filings for late-stage oncology programs. The role demands extensive experience in regulatory submissions, leading cross-functional teams, and a deep understanding of oncology drug development...Regulatory- ...seeking a Senior Medical Director with a strong background in clinical medicine and oncology. This role involves leading clinical science deliverables and ensuring the accuracy of data for regulatory submissions. The ideal candidate will have over 13 years in clinical...Regulatory
$211k - $264k
Revolution Medicines is searching for a Director, Global CMC Regulatory in Redwood City, California. This strategic role includes developing... ...CMC regulatory experience, particularly in managing complex submissions. The successful candidate will interpret regulatory guidance...RegulatoryWorldwide$164k - $205k
Revolution Medicines is a late-stage clinical oncology company developing... ...Operations, Data Management, Regulatory, CSV, Quality, and external... ...as the hands‑on system owner/lead for assigned clinical systems... ...standards and regulatory submission processes. The base pay salary...RegulatoryFull timeLocal area- Guardant Health in Palo Alto, CA, is seeking a Clinical Development Scientist to design and lead clinical validation studies for oncology IVD products, supporting regulatory submissions to FDA and other authorities. The role requires strong study design, data interpretation...Regulatory
$294k - $367k
A late-stage clinical oncology company is seeking a Vice President, Analytical Development... ...Redwood City, California. The VP will lead the analytical strategy across multiple... ...programs, ensuring robust quality control and regulatory compliance. Candidates should possess 18...Regulatory- Stanford Health Care is seeking a Senior Clinical Denials Appeal Specialist to resolve clinically related... ...medical records, and prepare evidence-based appeal submissions for payers. You will ensure compliance with regulatory requirements and internal standards while...Regulatory
- ...Senior Medical Director, Early-Stage Clinical Development Revolution Medicines is... ...and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-Designation... ...(AA). You will play a vital role in leading the clinical science aspects of the Clinical...Regulatory
$166.95k - $181k
Recor Medical is seeking a Senior Scientist to lead global external research programs aimed at treating hypertension. The successful candidate will manage clinical studies, ensuring compliance with regulatory standards while driving initiatives to lower blood pressure through...Regulatory- ...is looking for a Manager of Quality Control (QC) - Analytical in Newark, CA. You will lead analytical testing for clinical and commercial drug manufacturing in a GMP-regulated... ...This role involves ensuring compliance with regulatory standards and managing laboratory readiness...Regulatory
$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$30 - $35 per hour
...Prospectors Principal Recruiter at Digital Prospectors Position: Clinical Laboratory Associate Location: Redwood City, CA – Onsite Role... ...continuous process improvement. Ensure compliance with all regulatory and safety protocols. Qualifications: Associate degree required...RegulatoryContract workTemporary workDay shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Clinical Pharmacology QC Lead: Regulatory Submissions. Be the first to apply!
- regulatory executive Redwood City, CA
- regulatory law Redwood City, CA
- regulatory technician Redwood City, CA
- regulatory contract Redwood City, CA
- regulatory scientist Redwood City, CA
- regulatory engineer Redwood City, CA
- regulatory Redwood City, CA
- food regulatory Redwood City, CA
- director clinical pharmacology Redwood City, CA
- research assistant pharmacology Redwood City, CA

