Manager of Quality Assurance and Regulatory Affairs Jobs in San Diego, CA
Requirements Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred....
Company Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product...
Job Description: We are seeking a highly motivated and qualified individual to join our growing organization as an on-site Associate Director / Director, Regulatory Affairs and work as part of a...
Director, Regulatory Affairs - Gene Therapy
- San Diego, CA (12 miles from San Diego, CA)
- 30+ days ago
- San Diego, CA (12 miles from San Diego, CA)
- 30+ 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...
Lead global clinical trial application (CTA) activities, providing management and oversight of regulatory aspects of clinical trials....
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...
Remote WorkSenior Director Regulatory Affairs, Dispensing
- San Diego, CA
- 60+ days ago
- San Diego, CA
- 60+ days ago
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
Senior Director Regulatory Affairs (Dispensing and Pharmacy Automation Platforms)
- San Diego, CA
- 90+ days ago
- San Diego, CA
- 90+ days ago
development organizations Ensure Regulatory resources are available to support inspections conducted by global regulators Qualifications: M.S. degree in a technical discipline (e.g., engineering, biology...
The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and develop and execute...
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Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in San Diego, CA
Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in San Diego, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Molecular Cloning
- Animal Models
- Cancer Biology
- Immunofluorescence
- Gene Therapy
- Genotyping
- Cloning
- Water Testing
- Medical Affairs
- Lab Safety
- Assay Development
- ICH Guidelines
- Pharmacovigilance
- Clinical Laboratory Operations
- Experimental Design
- Quality Systems
- Institutional Review Board
- ISO 13485
- Medical Writing
- Drug Development
- GxP
- Change Control
- Microscopy
- Molecular Biology
- Biotechnology
- Quality Management Systems
- Polymerase Chain Reaction
- Laboratory Management
- Biology
- Microbiology
- Medical Device Sales
- Clinical Trials
- Good Manufacturing Practices
- Clinical Research
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Quality Control
- Collections
- Implementation
- Auditing
- Collaboration
- Documentation
- Reporting
- Mentoring
- Investigation
- Inventory Management
- Interpersonal Skills
- Education Experience
- Quality Assurance
- Policy Development
- Problem Solving
- Bachelor's Degree
- Project Management
- Regulations
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
- Fermentation
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