Director of Regulatory Affairs 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
- Dendreon Pharmaceuticals LLC
- Seal Beach, CA
- 7 hours ago
- Seal Beach, CA
- 7 hours ago
Job Summary: The Associate Director of Regulatory Affairs develops and executes global regulatory strategies to support product development, lifecycle management, and commercialization objectives....
In PersonSenior Director, Regulatory Affairs (Oncology)
- Exelixis
- Alameda, CA
- 14 hours ago
- Alameda, CA
- 14 hours ago
SUMMARY/JOB PURPOSE: Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements....
In PersonRegulatory Affairs Manager Vascular (on-site)
- Abbott Laboratories
- Santa Clara, CA
- 15 hours ago
- Santa Clara, CA
- 15 hours ago
PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions Experience with Class II and Class III medical devices Ability to define regulatory strategy....
In PersonDirector of Regulatory Affairs
- Radiant Nuclear
- El Segundo, CA
- 18 hours ago
- El Segundo, CA
- 18 hours ago
Director of Regulatory Affairs Radiant is seeking a highly engaging and effective leader for our regulatory and licensing team....
In PersonRegulatory Affairs Manager ABODE COMMUNITIES - 3.2 Los Angeles, CA Job Details Full-time $90,000 - $103,000 a year 16 hours ago Qualifications Stakeholder relationship building Full Job...
In PersonDirector, Regulatory Affairs Devices and Combination Products
- AbbVie, Inc
- Irvine, CA
- 5 days ago
- Irvine, CA
- 5 days ago
Job Description The Director Regulatory Affairs, Device is responsible for combining knowledge of scientific, regulatory and business issues to support and drive strategy for regulatory submissions,...
In PersonAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued,...
In PersonDirector, Regulatory Affairs CMC
- Kite Pharma
- Santa Monica, CA
- 6 days ago
- Santa Monica, CA
- 6 days ago
As a Director, Global Regulatory Affairs CMC, at Gilead you will...be responsible for providing global regulatory CMC leadership and strategy across the development, lifecycle management, and commercialization...
In PersonManager, Regulatory Affairs CMC
- 1010 Gilead Sciences, Inc.
- Foster City, CA
- 6 days ago
- Foster City, CA
- 6 days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
In PersonAssociate 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....
HybridManager, Regulatory Affairs CMC
- Gilead Sciences
- Foster City, CA
- 8 days ago
- Foster City, CA
- 8 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...
In PersonDirector, 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...
HybridDirector, Regulatory Affairs & Market Development
- WeaveGrid
- San Francisco, CA
- 11 days ago
- San Francisco, CA
- 11 days ago
About the Role In this role, you will help accelerate the adoption of utility EV managed charging and virtual power plant programs by shaping the regulatory, policy, and market conditions that...
In PersonRegulatory Affairs Manager Diabetes Care (on-site)
- Abbott
- Alameda, CA
- 12 days ago
- Alameda, CA
- 12 days ago
Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities....
In PersonDemographic Data for California
Moving to California? Find some basic demographic data about California below.
Director of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Director of Regulatory Affairs Jobs in California
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
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
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- Product Launch
- 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
Other Career Titles
Here are some other career titles that require similar skills
Director of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »