Manager of Regulatory Affairs Jobs in California
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.
Significant management experience with a proven track record of leading, mentoring, and scaling teams for a minimum of 8-10 years Deep understanding of FDA regulations, FSMA (21 CFR Part 117), DSHEA...
Oversee compliance with global regulatory standards including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR 820, EU MDR 2017/745, TG(MD)R Sch3, RDC ANVISA 665/2022, Japan MHLW 169, CMDR, NRC, BIS, DOT 49 CFR...
Strong knowledge of 21 CFR 820, 807, 814, 812, EU MDR 2017/745, Health Canada Medical Devices Regulations, TGA and PMDA requirements....
Director, Regulatory Affairs City : San Diego State : CA Country : US Job Term : Permanent Overview : PharmaLogics Recruiting is seeking a Director, Regulatory Affairs in San Diego, CA. Job...
Maintains a compliant Quality Management System in accordance with: ISO 9001 MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA 21 CFR 820) FDB,...
Remote WorkAssociate Director, Regulatory Affairs - Labeling Management
- San Jose, CA
- 3 days ago
- San Jose, CA
- 3 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Manager, Regulatory Affairs-Document Coordinator
- San Francisco, CA
- 6 days ago
- San Francisco, CA
- 6 days ago
regulations (ex-US is a plus) and industry standards pertaining to regulatory Knowledge of the drug development process and eCTD Excellent organization skills and ability to work on multiple projects...
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Regulatory Affairs Manager - Canada & Latin America - Diabetes Care (on-site)
- Alameda, CA
- 6 days ago
- Alameda, CA
- 6 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Commercial Regulatory Affairs Director (Advertising and Promotion)
- Alameda, CA
- 7 days ago
- Alameda, CA
- 7 days ago
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval...
Associate Director, Regulatory Affairs
- South San Francisco, CA
- 7 days ago
- South San Francisco, CA
- 7 days ago
The Position: Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise...
Senior Director, Regulatory Affairs
- South San Francisco, CA
- 8 days ago
- South San Francisco, CA
- 8 days ago
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle...
Regulatory Affairs Manager - APAC - Diabetes Care (on-site)
- Alameda, CA
- 8 days ago
- Alameda, CA
- 8 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
About the Role >>> Director, Regulatory Labeling As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of...
Demographic Data for California
Moving to California? Find some basic demographic data about California below.
Manager 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 Manager of Regulatory Affairs Jobs in California
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in California 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
- Biochemistry
- Biology
- Immunology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Manager 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 »
5 Quality Control Career Possibilities
As a specialty that spans numerous industries, QC offers many career paths. Which option is right for you? Read on to learn about the many possibilities available to QC professionals and find the opportunity that fits you best.
Read article »