Manager of Regulatory Affairs Jobs in Hawthorne, CA
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
- Culver City, CA (6 miles from Hawthorne, CA)
- 13 days ago
- Culver City, CA (6 miles from Hawthorne, CA)
- 13 days ago
DIRECTOR, REGULATORY AFFAIRS (Hybrid) Job Summary: We are seeking a dedicated and talented Director of Regulatory Affairs to join our team. In this role, you will The Director of Regulatory will...
Senior Manager, Regulatory Affairs
- El Segundo, CA (3 miles from Hawthorne, CA)
- 19 days ago
- El Segundo, CA (3 miles from Hawthorne, CA)
- 19 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)
- 22 days ago
- Santa Monica, CA (11 miles from Hawthorne, CA)
- 22 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...
- Santa Monica, CA (11 miles from Hawthorne, CA)
- 27 days ago
- Santa Monica, CA (11 miles from Hawthorne, CA)
- 27 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
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- Los Angeles, CA (6 miles from Hawthorne, CA)
- 30+ days ago
- Los Angeles, CA (6 miles from Hawthorne, CA)
- 30+ days ago
What Youll be Doing The Manager of Regulatory Affairs will spearhead all regulatory compliance and safety reviews for the brands new product development launch calendar while maintaining compliance...
The Manager, Regulatory Affairs serves as the domestic and global regulatory contact at Alchemee....
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Salary for Manager of Regulatory Affairs Jobs in Hawthorne, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager 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 Manager of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- TrackWise
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- 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
- Leadership
- Communication Skills
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