Director of Regulatory Affairs Remote & Hybrid Only Jobs in California
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Associate Director, Regulatory Affairs Advertising and Promotion
- Mirum Pharmaceuticals Inc
- Foster City, CA
- 6 days ago
- Foster City, CA
- 6 days ago
This role will report to the Director, Global Regulatory Affairs Advertising and Promotion....
HybridDirector, Regulatory Affairs (Clinical)
- Bayside Solutions
- Redwood City, CA
- 10 days ago
- Redwood City, CA
- 10 days ago
Director, Regulatory Affairs (Clinical) in Redwood City, California Overview Director, Regulatory Affairs (Clinical) W2 Contract Pay Rate: $100 - $125 per hour Location: Redwood City, CA - Remote Role...
RemoteAssociate Director, Regulatory Affairs Project Planning & Coordination
- ACADIA Pharmaceuticals Inc.
- South San Francisco, CA
- 10 days ago
- South San Francisco, CA
- 10 days ago
Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate...
Hybrid- BridgeBio Pharma, Inc.
- San Francisco, CA
- 12 days ago
- San Francisco, CA
- 12 days ago
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a...
Remote HybridAssociate Director, Regulatory Affairs
- Maze Therapeutics
- South San Francisco, CA
- 21 days ago
- South San Francisco, CA
- 21 days ago
The Opportunity: Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise and...
Hybrid- Revolution Medicines
- Redwood City, CA
- 27 days ago
- Redwood City, CA
- 27 days ago
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R D pipeline comprises RAS(ON) inhibitors...
RemoteAssociate Director, Regulatory Affairs
- Allogene Therapeutics, Inc.
- South San Francisco, CA
- 30+ days ago
- South San Francisco, CA
- 30+ days ago
About the role: Allogene is seeking an Associate Director, Regulatory Affairs within the Global Regulatory Affairs and Clinical Quality organization who will manage worldwide interactions and negotiations...
HybridSenior Manager, Regulatory Affairs
- Hyperfine Inc
- Palo Alto, CA
- 45+ days ago
- Palo Alto, CA
- 45+ days ago
Lead preparation, publishing, and maintenance of regulatory submissions (e.g., FDA 510(k)s, Q-Sub/Pre-Sub interactions as needed, and international registrations such as EU MDR/UKCA, Canada, Australia...
HybridSenior Manager, Regulatory Affairs
- Revolution Medicines, Inc.
- Redwood City, CA
- 60+ days ago
- Redwood City, CA
- 60+ days ago
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors...
Hybrid- Revolution Medicines, Inc.
- Redwood City, CA
- 60+ days ago
- Redwood City, CA
- 60+ days ago
The Opportunity: The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed....
HybridAssociate Director, Regulatory Affairs Advertising & Promotion (Office-based)
- AbbVie, Inc
- Irvine, CA
- 60+ days ago
- Irvine, CA
- 60+ days ago
Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...
HybridAssociate Director, Regulatory Affairs CMC
- Crinetics Pharmaceuticals
- San Diego, CA
- 90+ days ago
- San Diego, CA
- 90+ days ago
Position Summary: The Associate Director, Regulatory Affairs CMC will be responsible for supporting regulatory strategy implementation for development programs....
RemoteDirector, Regulatory Affairs CMC
- Corcept Therapeutics
- Redwood City, CA
- 90+ days ago
- Redwood City, CA
- 90+ days ago
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial...
HybridDemographic Data for California
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Director of 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 Regulatory Affairs position
- Clinical Research
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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