Director of Regulatory Affairs Jobs in Irvine, 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 US Advertising and Promotion - Neuroscience
- East Irvine, CA (5 miles from Irvine, CA)
- 2 days ago
- East Irvine, CA (5 miles from Irvine, CA)
- 2 days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Strong knowledge of global medical device regulations and quality systems. Experience with EU MDR implementation is a plus....
About the Role The Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) will lead the development and execution of CMC regulatory strategy for the Company's assets....
- Irvine, CA
- 30+ days ago
- Irvine, CA
- 30+ days ago
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product...
- Santa Ana, CA (6 miles from Irvine, CA)
- 30+ days ago
- Santa Ana, CA (6 miles from Irvine, CA)
- 30+ days ago
The Companys facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China...
Future Opportunities - Join Our Talent Pipeline for Director Regulatory Affairs, Global Regulatory
- East Irvine, CA (5 miles from Irvine, CA)
- 45+ days ago
- East Irvine, CA (5 miles from Irvine, CA)
- 45+ days ago
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product...
- Newport Beach, CA (11 miles from Irvine, CA)
- 45+ days ago
- Newport Beach, CA (11 miles from Irvine, CA)
- 45+ days ago
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products.We are seeking an experienced and driven Regulatory Affairs Manager to join our...
- Buena Park, CA (16 miles from Irvine, CA)
- 45+ days ago
- Buena Park, CA (16 miles from Irvine, CA)
- 45+ days ago
Description Ensure that marketing and information is within regulations for advertisements, e comm platforms, social media and US and global markets Assist with expansion into newer markets like...
Demographic Data for Irvine, CA
Moving to Irvine, CA? Find some basic demographic data about Irvine, CA below.
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Salary for Director of Regulatory Affairs Jobs in Irvine, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Irvine, 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
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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