Manager of Regulatory Affairs Jobs in San Francisco, 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/Senior Director, Regulatory Affairs, Therapeutics
- Brisbane, CA (6 miles from San Francisco, CA)
- 1 day ago
- Brisbane, CA (6 miles from San Francisco, CA)
- 1 day ago
Associate) Director/Senior Director, Regulatory Affairs, Therapeutics in Brisbane Job Ref: ... Employer: Network Company Name: Mammoth Biosciences Industry: Executive Job Type: Full Time State:...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Brisbane, CA (6 miles from San Francisco, CA)
- 6 days ago
- Brisbane, CA (6 miles from San Francisco, CA)
- 6 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
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 and executional...
Director Of Regulatory Affairs (San Francisco, Ca)
- San Francisco, CA
- 14 days ago
- San Francisco, CA
- 14 days ago
Director of Regulatory Affairs (San Francisco, CA)Summary:This role provides global regulatory leadership and expertise to ensure compliance and successful submission of clinical regulatory...
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Director/Sr. Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA
- 14 days ago
- San Francisco, CA
- 14 days ago
At Nurix, we believe in the science of possibility.We are committed to advancing groundbreaking science and innovation in targeted protein degradation to transform patients' lives.If you're...
- South San Francisco, CA (8 miles from San Francisco, CA)
- 16 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 16 days ago
Regulatory Affairs Director Department: Regulatory Affairs Location: South San Francisco, CA POSITION SUMMARY: Reporting to the Vice President of Regulatory Affairs, this position is specifically...
Associate Director, Regulatory Affairs
- South San Francisco, CA (8 miles from San Francisco, CA)
- 23 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 23 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 (23 miles from San Francisco, CA)
- 27 days ago
- Redwood City, CA (23 miles from San Francisco, CA)
- 27 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 (23 miles from San Francisco, CA)
- 28 days ago
- Redwood City, CA (23 miles from San Francisco, CA)
- 28 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...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (8 miles from San Francisco, CA)
- 29 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 29 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 (17 miles from San Francisco, CA)
- 29 days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 29 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- San Francisco, CA
- 30+ days ago
- San Francisco, CA
- 30+ 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...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 45+ days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 45+ 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...
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 45+ days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 45+ 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...
Director, Regulatory Affairs-CMC
- South San Francisco, CA (8 miles from San Francisco, CA)
- 45+ days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 45+ days ago
Support product development, manufacturing changes, and quality systems compliance across the product lifecycle....
Demographic Data for San Francisco, CA
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Manager of Regulatory Affairss in San Francisco, 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
- 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
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