Manager of Regulatory Affairs Jobs in Pleasanton, CA
- San Jose, CA (20 miles from Pleasanton, CA)
- 1 day ago
- San Jose, CA (20 miles from Pleasanton, CA)
- 1 day ago
The Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global...
Sr Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair (on-site)
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 5 days ago
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 5 days ago
Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities....
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 6 days ago
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 6 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...
Senior Director / Executive Director of Regulatory Affairs
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 8 days ago
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 8 days ago
Senior Director / Executive Director of Regulatory Affairs W2 Contract-to-Hire Salary Range: $343,200 - $364,000 per year Location: Redwood City, CA - Hybrid or Remote PST Duties and...
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 9 days ago
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 9 days ago
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease...
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 11 days ago
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 11 days ago
Position OverviewWe are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas.This role will be...
Sr Manager, Regulatory Affairs
- Redwood City, CA (24 miles from Pleasanton, CA)
- 24 days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 24 days ago
Sr Manager, Regulatory Affairs at Corcept Therapeutics Redwood City, California, United States Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate...
Senior Manager, Regulatory Affairs
- Redwood City, CA (24 miles from Pleasanton, CA)
- 25 days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 25 days ago
The Opportunity: The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA (23 miles from Pleasanton, CA)
- 26 days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 26 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various...
Executive Director, Regulatory Affairs
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 30+ days ago
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 30+ days ago
Job Description Primary Function of Position As Senior Manager, Regulatory Affairs, you will lead and manage a team responsible for developing and executing regulatory strategies within the Multiport...
Director, Regulatory Affairs Global Labeling
- Foster City, CA (23 miles from Pleasanton, CA)
- 30+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 30+ days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Senior Manager, Regulatory Affairs
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 45+ days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 45+ 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....
- Oakland, CA (21 miles from Pleasanton, CA)
- 60+ days ago
- Oakland, CA (21 miles from Pleasanton, CA)
- 60+ days ago
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages...
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Manager of Regulatory Affairss in Pleasanton, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Biomarkers
- Gene Therapy
- Next-Generation Sequencing
- Drug Discovery
- Medical Affairs
- 21 CFR 820
- Internal Audits
- Pharmacovigilance
- Assay Development
- ICH Guidelines
- Drug Development
- Immunology
- Change Control
- Quality Systems
- ISO 13485
- Quality Management Systems
- Biotechnology
- Neurology
- Oncology
- Medical Device Sales
- Clinical Trials
- Document Management
- Biology
- FDA Regulations
- Research and Development
- Clinical Research
- Resolution
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Strategy Development
- Engineering
- Implementation
- Written Communication
- Military Background
- Verbal Communication
- Collaboration
- Investigation
- Auditing
- Documentation
- Interpersonal Skills
- Mentoring
- Quality Assurance
- Reporting
- Coaching
- Education Experience
- Bachelor's Degree
- Regulations
- Problem Solving
- Project Management
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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