Manager of Regulatory Affairs Jobs in Orange, 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.
Associate Director, Regulatory Affairs
- Dendreon Pharmaceuticals LLC
- Seal Beach, CA (13 miles from Orange, CA)
- 10 hours ago
- Seal Beach, CA (13 miles from Orange, CA)
- 10 hours ago
Overview Who We Are: At Dendreon, were transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved...
In PersonDirector, Regulatory Affairs Devices and Combination Products
- AbbVie, Inc
- Irvine, CA (6 miles from Orange, CA)
- 5 days ago
- Irvine, CA (6 miles from Orange, CA)
- 5 days ago
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of...
In PersonRegulatory Affairs & Quality Assurance Manager
- University of California System
- Orange, CA
- 13 days ago
- Orange, CA
- 13 days ago
Responsibilities Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Manager of Regulatory Affairs and Quality Assurance...
In PersonDirector, Regulatory Affairs Strategy
- Alcon
- Lake Forest, CA (15 miles from Orange, CA)
- 17 days ago
- Lake Forest, CA (15 miles from Orange, CA)
- 17 days ago
At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global...
In PersonManager, Regulatory Affairs THV
- Edwards Lifesciences
- Irvine, CA (6 miles from Orange, CA)
- 30+ days ago
- Irvine, CA (6 miles from Orange, CA)
- 30+ days ago
(e.g., ITA's, IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files) Provide guidance on regulatory requirements necessary for strategic and contingency planning...
In PersonProject Manager, Regulatory Affairs (VALVE)
- JENAVALVE TECHNOLOGY INC
- Irvine, CA (6 miles from Orange, CA)
- 45+ days ago
- Irvine, CA (6 miles from Orange, CA)
- 45+ days ago
Title : Project Manager, Regulatory Affairs Role Level: Individual Contributor Supervisor/Manager Title: Senior Manager, Regulatory Affairs Job Location & Environment: Irvine, CA - Corporate Office...
In PersonAssociate Director, Regulatory Affairs Advertising & Promotion (Office-based)
- AbbVie, Inc
- Irvine, CA (6 miles from Orange, CA)
- 60+ days ago
- Irvine, CA (6 miles from Orange, CA)
- 60+ days ago
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of...
HybridSystem Monitoring the impact of changing global regulations on submission strategies & registrations Support external and internal audits Perform other regulatory-related duties as assigned....
In PersonDemographic Data for Orange, CA
Moving to Orange, CA? Find some basic demographic data about Orange, CA below.
Manager of Regulatory Affairs Online Courses and Training Opportunities
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Salary for Manager of Regulatory Affairs Jobs in Orange, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Orange, 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
- 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
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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