Director of Regulatory Affairs Jobs in Los Angeles, 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 of Regulatory Affairs
- El Segundo, CA (9 miles from Los Angeles, CA)
- 1 day ago
- El Segundo, CA (9 miles from Los Angeles, CA)
- 1 day ago
About the role: The Director of Regulatory Affairs leads the Regulatory Affairs team and its strategic initiatives within the fast-evolving food and dietary supplement industry....
Director, FDA Regulatory Affairs & Food Safety while assuring FDA, other federal, state, and local government and all applicable regulatory compliance for Central products....
Associate Director, Regulatory Affairs - CMC (Cell Therapy)
- Santa Monica, CA (14 miles from Los Angeles, CA)
- 16 days ago
- Santa Monica, CA (14 miles from Los Angeles, CA)
- 16 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...
Manager, Regulatory Affairs (MLR Coordinator)
- Pasadena, CA (13 miles from Los Angeles, CA)
- 18 days ago
- Pasadena, CA (13 miles from Los Angeles, CA)
- 18 days ago
The Position The Regulatory Affairs MLR Manager is responsible for managing the MLR review and approval process. The Manager will schedule review meetings with the U.S. MLR team as well as the...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for contributing...
This team member reports into the Director of Regulatory Affairs and is responsible for the management and leadership of Regulatory Affairs activities for implantable cardiac pacemaker and defibrillator...
- Torrance, CA (10 miles from Los Angeles, CA)
- 30+ days ago
- Torrance, CA (10 miles from Los Angeles, CA)
- 30+ days ago
Director, Regulatory Affairs-Americas and provide leadership and management direction for all product-related regulatory matters in countries designated by the department....
- Culver City, CA (8 miles from Los Angeles, CA)
- 45+ days ago
- Culver City, CA (8 miles from Los Angeles, CA)
- 45+ days ago
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 (9 miles from Los Angeles, CA)
- 45+ days ago
- El Segundo, CA (9 miles from Los Angeles, CA)
- 45+ 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...
- Hawthorne, CA (7 miles from Los Angeles, CA)
- 90+ days ago
- Hawthorne, CA (7 miles from Los Angeles, CA)
- 90+ 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 Los Angeles, CA
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Salary for Director of Regulatory Affairs Jobs in Los Angeles, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Los Angeles, 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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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