Director of Quality Assurance and Regulatory Affairs Remote & Hybrid Only Jobs in California
Director, Regulatory Affairs - Gene Therapy
- Insmed Incorporated
- San Diego, CA
- 13 days ago
- San Diego, CA
- 13 days ago
direct application of US/EU/Japan/International regulations, regional guidance documents and ICH guidance documents Regulatory writing and/or review of documents supporting product development and clinical...
RemoteDirector/Sr. Director, Quality Assurance
- BridgeBio Pharma, Inc.
- San Francisco, CA
- 14 days ago
- San Francisco, CA
- 14 days ago
Director, Quality Assurance is responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program at BridgeBio....
HybridDirector, Regulatory Affairs (Clinical Strategy/Regulatory)
- Bayside Solutions
- Redwood City, CA
- 19 days ago
- Redwood City, CA
- 19 days ago
Director, Regulatory Affairs (Clinical Strategy/Regulatory) in Redwood City, California Overview Director, Regulatory Affairs (Clinical Strategy/Regulatory) W2 Contract-to-Hire Salary Range:...
Hybrid- Cytokinetics, Incorporated
- South San Francisco, CA
- 27 days ago
- South San Francisco, CA
- 27 days ago
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new...
HybridSenior Manager Regulatory Affairs
- Groe Advisors LLC
- Aliso Viejo, CA
- 27 days ago
- Aliso Viejo, CA
- 27 days ago
Knowledge, Skills, and Competencies: Deep knowledge of 21 CFR, FDA/ICH guidelines, GxPs, and applicable EU regulatory frameworks....
HybridSr. Manager, Regulatory Affairs Cell and Gene Therapy
- 0100 Invitrogen Holdings LLC
- Carlsbad, CA
- 30+ days ago
- Carlsbad, CA
- 30+ days ago
Return to selected search result Sr. Manager, Regulatory Affairs Cell and Gene Therapy Apply remote type Fully Remote locations Remote, California, USA Frederick, Maryland, USA Waltham,...
RemoteSr. Manager, Regulatory Affairs Cell and Gene Therapy
- ThermoFisher Scientific
- CA
- 30+ days ago
- CA
- 30+ days ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a...
RemoteSenior Director, Regulatory Affairs (Office or Remote)
- Arcus Biosciences, Inc.
- Brisbane, CA
- 30+ days ago
- Brisbane, CA
- 30+ days ago
trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA)/Biologic Licensure Application...
RemoteDirector_Sr. Director, Regulatory Affairs
- Abdera Therapeutics
- South San Francisco, CA
- 45+ days ago
- South San Francisco, CA
- 45+ days ago
Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology....
HybridAssociate Director, Regulatory Affairs
- Maze Therapeutics
- South San Francisco, CA
- 45+ days ago
- South San Francisco, CA
- 45+ days ago
: Bachelor's degree required; advanced degree in life sciences preferred. 7+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry Strong understanding of ICH...
HybridAssociate Director, Regulatory Affairs
- Revolution Medicines, Inc.
- Redwood City, CA
- 60+ days ago
- Redwood City, CA
- 60+ days ago
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
Hybrid- Revolution Medicines, Inc.
- Redwood City, CA
- 90+ days ago
- Redwood City, CA
- 90+ days ago
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
HybridDirector, Quality Assurance GCP
- Crinetics Pharmaceuticals
- San Diego, CA
- 90+ days ago
- San Diego, CA
- 90+ days ago
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These may include but are not limited to: General Provide GCP quality assurance strategy and oversight of QA GCP operations Ensures that clinical trials and...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in California offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Study Management
- DNA/RNA Extraction
- Molecular Cloning
- Immunofluorescence
- Gene Therapy
- Next Generation Sequencing
- Virology
- Transfection
- Pharmacovigilance
- Internal Audits
- Medical Affairs
- Batch Record Review
- Lab Safety
- ICH Guidelines
- Drug Development
- Clinical Laboratory Operations
- Experimental Design
- ISO 13485
- GxP
- Good Clinical Practice
- Quality Systems
- Good Laboratory Practice
- Enzyme-Linked ImmunoSorbent Assay
- Microscopy
- Cell Culture
- Molecular Biology
- Biotechnology
- Biology
- Quality Management Systems
- Polymerase Chain Reaction
- Laboratory Management
- Microbiology
- Validation
- Clinical Trials
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Continuous Improvement
- Strategy Development
- Engineering
- Quality Control
- Implementation
- Auditing
- Documentation
- Collaboration
- Interpersonal Skills
- Investigation
- Reporting
- Inventory Management
- Mentoring
- Quality Assurance
- Bachelor's Degree
- Policy Development
- Education Experience
- Project Management
- Research Skills
- Regulations
- Microsoft Office
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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