Director of Regulatory Affairs Jobs in Culver City, CA
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.
DIRECTOR, REGULATORY AFFAIRS (Hybrid) Job Summary: We are seeking a dedicated and talented Director of Regulatory Affairs to join our team....
Senior Manager, Regulatory Affairs
- El Segundo, CA (5 miles from Culver City, CA)
- 12 days ago
- El Segundo, CA (5 miles from Culver City, CA)
- 12 days ago
BS Degree in Regulatory Science, Food Science/Technology, Nutrition, or related scientific field 4-6 years of relevant regulatory experience in the food/supplement industry Strong understanding of FDA...
Associate Director, Regulatory Affairs - CMC (Cell Therapy)
- Santa Monica, CA (5 miles from Culver City, CA)
- 15 days ago
- Santa Monica, CA (5 miles from Culver City, CA)
- 15 days ago
Position Summary The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline...
- Santa Monica, CA (5 miles from Culver City, CA)
- 20 days ago
- Santa Monica, CA (5 miles from Culver City, CA)
- 20 days ago
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible...
Remote Work- Los Angeles, CA (8 miles from Culver City, CA)
- 29 days ago
- Los Angeles, CA (8 miles from Culver City, CA)
- 29 days ago
REGULATORY AFFAIRS MANAGER LOS ANGELES, CA Who We Are Tower 28 is a clean beauty brand born and bred in Santa Monica. All products are designed for sensitive skin, high-performance, and 100%...
- Hawthorne, CA (6 miles from Culver City, CA)
- 60+ days ago
- Hawthorne, CA (6 miles from Culver City, CA)
- 60+ days ago
Strong knowledge/application of US FDA regulations, Health Canada regulations, EU/Brexit regulations, Japan (MHLW) regulations, PMDA, Prop 65, guidance documents and validation requirements....
Demographic Data for Culver City, CA
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Salary for Director of Regulatory Affairs Jobs in Culver City, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Culver City, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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