Director of Regulatory Affairs Jobs in Menlo Park, CA
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (22 miles from Menlo Park, CA)
- 45+ days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 45+ 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...
Director, Regulatory Affairs-CMC
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 1 day ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 1 day ago
The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs....
Sr Manager, Regulatory Affairs (Remote) - Shockwave
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 4 days ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 4 days ago
management system audits for geographies outside of US and EU (e.g., MDSAP, KGMP, Japan QMS, etc.)...
Remote WorkOverview 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 (3 miles from Menlo Park, CA)
- 5 days ago
- Redwood City, CA (3 miles from Menlo Park, CA)
- 5 days ago
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
- Oakland, CA (22 miles from Menlo Park, CA)
- 12 days ago
- Oakland, CA (22 miles from Menlo Park, CA)
- 12 days ago
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages...
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 15 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 15 days ago
Regulatory Affairs Manager II | REMOTE ROLE | PST Hours We are seeking a Regulatory Affairs Manager II to support global regulatory initiatives and ensure compliance with regulatory requirements...
Remote WorkAssociate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (8 miles from Menlo Park, CA)
- 18 days ago
- Foster City, CA (8 miles from Menlo Park, 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 (8 miles from Menlo Park, CA)
- 18 days ago
- Foster City, CA (8 miles from Menlo Park, 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 (8 miles from Menlo Park, CA)
- 18 days ago
- Foster City, CA (8 miles from Menlo Park, 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...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 20 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 20 days ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the worlds...
Executive Director, Regulatory Affairs CMC
- Alameda, CA (22 miles from Menlo Park, CA)
- 25 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 25 days ago
SUMMARY/JOB PURPOSE: This role provides CMC Regulatory expertise and leadership for commercial and development projects. This role leads all regulatory activities related to chemistry,...
- San Mateo, CA (10 miles from Menlo Park, CA)
- 27 days ago
- San Mateo, CA (10 miles from Menlo Park, CA)
- 27 days ago
the job to your shortlist Job Details Company Job Details Director, Regulatory Affairs I am working with a innovative biotech company is seeking a Director of Regulatory Affairs to lead regulatory efforts...
Associate Director, Regulatory Affairs CMC
- Foster City, CA (8 miles from Menlo Park, CA)
- 30+ days ago
- Foster City, CA (8 miles from Menlo Park, 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 (22 miles from Menlo Park, CA)
- 45+ days ago
- Pleasanton, CA (22 miles from Menlo Park, 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....
Demographic Data for Menlo Park, CA
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Director of Regulatory Affairss in Menlo Park, 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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