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.
Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management....
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....
Demographic Data for Irvine, CA
Moving to Irvine, CA? Find some basic demographic data about Irvine, CA below.
Director of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- 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
- Coaching
- Bachelor's Degree
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »