Director of Regulatory Affairs Jobs in San Francisco, 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 Director, Regulatory Affairs Strategy and Compliance
- San Mateo, CA (15 miles from San Francisco, CA)
- 19 hours ago
- San Mateo, CA (15 miles from San Francisco, CA)
- 19 hours ago
General Description:** The Senior Director, Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive regulatory strategies to ensure compliance with global...
(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics
- Brisbane, CA (6 miles from San Francisco, CA)
- 4 days ago
- Brisbane, CA (6 miles from San Francisco, CA)
- 4 days ago
Associate) Director/Senior Director, Regulatory Affairs, Therapeutics in Brisbane Job Ref: ......
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Brisbane, CA (6 miles from San Francisco, CA)
- 8 days ago
- Brisbane, CA (6 miles from San Francisco, CA)
- 8 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...
Director Of Regulatory Affairs (San Francisco, Ca)
- San Francisco, CA
- 17 days ago
- San Francisco, CA
- 17 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 filings.The...
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Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA
- 17 days ago
- San Francisco, CA
- 17 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...
Associate Director, Regulatory Affairs
- South San Francisco, CA (8 miles from San Francisco, CA)
- 26 days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 26 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 and...
Sr Manager, Regulatory Affairs
- Redwood City, CA (23 miles from San Francisco, CA)
- 30+ days ago
- Redwood City, CA (23 miles from San Francisco, CA)
- 30+ 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...
Senior Manager, Regulatory Affairs
- Redwood City, CA (23 miles from San Francisco, CA)
- 30+ days ago
- Redwood City, CA (23 miles from San Francisco, CA)
- 30+ 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...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (8 miles from San Francisco, CA)
- 30+ days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 30+ 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)
- 30+ days ago
- Foster City, CA (17 miles from San Francisco, CA)
- 30+ 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)
- 60+ days ago
- South San Francisco, CA (8 miles from San Francisco, CA)
- 60+ days ago
The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs....
- Oakland, CA (11 miles from San Francisco, CA)
- 60+ days ago
- Oakland, CA (11 miles from San Francisco, CA)
- 60+ days ago
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages...
Demographic Data for San Francisco, CA
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Director 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 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
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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