Director of Regulatory Affairs Jobs in Santa Clara, CA
Sr Manager, Regulatory Affairs (Remote) - Shockwave
- Santa Clara, CA
- 4 days ago
- Santa Clara, CA
- 4 days ago
management system audits for geographies outside of US and EU (e.g., MDSAP, KGMP, Japan QMS, etc.)...
Remote WorkSenior Manager, Regulatory Affairs
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 4 days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 4 days ago
Overview of Role: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects...
Associate Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 5 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 5 days ago
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
Associate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 days ago
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products....
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 days ago
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...
Associate Director, Regulatory Affairs
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 days ago
POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization...
Associate Director, Regulatory Affairs CMC
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
Job Description We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site....
Manager, Regulatory Affairs- Body Contouring
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 45+ days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 45+ days ago
Knowledge of FDA QSR, ISO 13485 and other regulations/standards. Ability to focus on and achieve scheduled milestones, including contingency planning....
Director / Senior Director, Regulatory Affairs Labeling, Advertising, and Promotion
- Redwood City, CA (17 miles from Santa Clara, CA)
- 60+ days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 60+ days ago
About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...
Director / Senior Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 60+ days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 60+ days ago
Affairs....
Director, Regulatory Affairs Data Governance Lead
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
Evaluate and implement data quality management tools and technologies to improve business operations and data quality....
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 60+ days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 60+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
The Opportunity: The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed....
Digital Tech Manager - Regulatory Affairs
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 90+ days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 90+ days ago
Clorox is the place thats committed to growth for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can...
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Director of Regulatory Affairss in Santa Clara, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Biomarkers
- Drug Discovery
- Pharmacovigilance
- Medical Writing
- Medical Affairs
- 21 CFR 820
- GxP
- Assay Development
- ICH Guidelines
- Drug Development
- Good Laboratory Practice
- Immunology
- Change Control
- Scientific Writing
- Quality Systems
- Good Clinical Practice
- Infectious Disease
- ISO 13485
- Neuroscience
- Quality Management Systems
- Microbiology
- Biotechnology
- Oncology
- Medical Device Sales
- Clinical Trials
- Document Management
- Biology
- FDA Regulations
- Clinical Research
- Research and Development
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Affirmative Action
- Implementation
- Military Background
- Written Communication
- Verbal Communication
- Auditing
- Collaboration
- Documentation
- Mentoring
- Interpersonal Skills
- Quality Assurance
- Reporting
- English
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
- Gene Therapy
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