Manager of Regulatory Affairs Jobs in Foster City, 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.
Director/Sr. Director, Regulatory Affairs
- San Francisco, CA (17 miles from Foster City, CA)
- 5 hours ago
- San Francisco, CA (17 miles from Foster City, CA)
- 5 hours ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
- Alameda, CA (15 miles from Foster City, CA)
- 1 day ago
- Alameda, CA (15 miles from Foster City, CA)
- 1 day ago
The Opportunity The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or...
Associate Director, Regulatory Affairs
- South San Francisco, CA (11 miles from Foster City, CA)
- 4 days ago
- South San Francisco, CA (11 miles from Foster City, CA)
- 4 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...
Sr Manager, Regulatory Affairs
- Redwood City, CA (6 miles from Foster City, CA)
- 8 days ago
- Redwood City, CA (6 miles from Foster City, CA)
- 8 days ago
Sr Manager, Regulatory Affairs at Corcept Therapeutics Redwood City, California, United States Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate...
Senior Manager, Regulatory Affairs
- Redwood City, CA (6 miles from Foster City, CA)
- 8 days ago
- Redwood City, CA (6 miles from Foster City, CA)
- 8 days ago
The Opportunity: The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments...
Director of Regulatory Affairs
- Berkeley, CA (21 miles from Foster City, CA)
- 9 days ago
- Berkeley, CA (21 miles from Foster City, CA)
- 9 days ago
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (11 miles from Foster City, CA)
- 9 days ago
- South San Francisco, CA (11 miles from Foster City, CA)
- 9 days ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA
- 10 days ago
- Foster City, CA
- 10 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- Redwood City, CA (6 miles from Foster City, CA)
- 10 days ago
- Redwood City, CA (6 miles from Foster City, CA)
- 10 days ago
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...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (8 miles from Foster City, CA)
- 15 days ago
- Menlo Park, CA (8 miles from Foster City, CA)
- 15 days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various...
Executive Director, Regulatory Affairs
- Menlo Park, CA (8 miles from Foster City, CA)
- 15 days ago
- Menlo Park, CA (8 miles from Foster City, CA)
- 15 days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Manager, Regulatory Affairs Strategy
- Pleasanton, CA (23 miles from Foster City, CA)
- 19 days ago
- Pleasanton, CA (23 miles from Foster City, CA)
- 19 days ago
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Associate Director, Regulatory Affairs
- San Francisco, CA (17 miles from Foster City, CA)
- 21 days ago
- San Francisco, CA (17 miles from Foster City, CA)
- 21 days ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
- Sunnyvale, CA (17 miles from Foster City, CA)
- 21 days ago
- Sunnyvale, CA (17 miles from Foster City, CA)
- 21 days ago
Job Description Primary Function of Position As Senior Manager, Regulatory Affairs, you will lead and manage a team responsible for developing and executing regulatory strategies within the Multiport...
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)
- Alameda, CA (15 miles from Foster City, CA)
- 28 days ago
- Alameda, CA (15 miles from Foster City, CA)
- 28 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...
Demographic Data for Foster City, CA
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Salary for Manager of Regulatory Affairs Jobs in Foster City, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Foster City, 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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