Director of Regulatory Affairs Jobs in Hawthorne, 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.
Senior Manager, Regulatory Affairs
- El Segundo, CA (3 miles from Hawthorne, CA)
- 2 days ago
- El Segundo, CA (3 miles from Hawthorne, CA)
- 2 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 (11 miles from Hawthorne, CA)
- 5 days ago
- Santa Monica, CA (11 miles from Hawthorne, CA)
- 5 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 (11 miles from Hawthorne, CA)
- 10 days ago
- Santa Monica, CA (11 miles from Hawthorne, CA)
- 10 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 (6 miles from Hawthorne, CA)
- 19 days ago
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 19 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%...
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 Hawthorne, CA
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Salary for Director of Regulatory Affairs Jobs in Hawthorne, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Hawthorne, 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
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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