Director of Regulatory Affairs Jobs in Foster City, 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 CMC
- San Mateo, CA (3 miles from Foster City, CA)
- 1 day ago
- San Mateo, CA (3 miles from Foster City, CA)
- 1 day ago
General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team...
Senior Director, Regulatory Affairs Strategy and Compliance
- San Mateo, CA (3 miles from Foster City, CA)
- 2 days ago
- San Mateo, CA (3 miles from Foster City, CA)
- 2 days 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 (12 miles from Foster City, CA)
- 6 days ago
- Brisbane, CA (12 miles from Foster City, CA)
- 6 days ago
Associate) Director/Senior Director, Regulatory Affairs, Therapeutics in Brisbane Job Ref: ......
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Brisbane, CA (12 miles from Foster City, CA)
- 10 days ago
- Brisbane, CA (12 miles from Foster City, CA)
- 10 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...
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Associate Director, Regulatory Affairs
- San Francisco, CA (17 miles from Foster City, CA)
- 12 days ago
- San Francisco, CA (17 miles from Foster City, CA)
- 12 days ago
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 leadership...
Sr Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair (on-site)
- Santa Clara, CA (22 miles from Foster City, CA)
- 12 days ago
- Santa Clara, CA (22 miles from Foster City, CA)
- 12 days ago
Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities....
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA (22 miles from Foster City, CA)
- 13 days ago
- Santa Clara, CA (22 miles from Foster City, CA)
- 13 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 - Heart Failure (on-site)
- Pleasanton, CA (23 miles from Foster City, CA)
- 15 days ago
- Pleasanton, CA (23 miles from Foster City, CA)
- 15 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...
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA (10 miles from Foster City, CA)
- 17 days ago
- Palo Alto, CA (10 miles from Foster City, CA)
- 17 days ago
Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team....
Director Of Regulatory Affairs (San Francisco, Ca)
- San Francisco, CA (17 miles from Foster City, CA)
- 19 days ago
- San Francisco, CA (17 miles from Foster City, CA)
- 19 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...
Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA (17 miles from Foster City, CA)
- 19 days ago
- San Francisco, CA (17 miles from Foster City, CA)
- 19 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...
- Palo Alto, CA (10 miles from Foster City, CA)
- 19 days ago
- Palo Alto, CA (10 miles from Foster City, CA)
- 19 days ago
Position OverviewWe are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas.This role will be responsible...
- San Francisco, CA (17 miles from Foster City, CA)
- 21 days ago
- San Francisco, CA (17 miles from Foster City, CA)
- 21 days ago
The Position Join Maze Therapeutics as a Director, Regulatory Affairs, where you will play a critical leadership role in advancing our clinical-stage programs, providing regulatory expertise to guide...
Associate Director, Regulatory Affairs
- South San Francisco, CA (11 miles from Foster City, CA)
- 28 days ago
- South San Francisco, CA (11 miles from Foster City, CA)
- 28 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 (6 miles from Foster City, CA)
- 30+ days ago
- Redwood City, CA (6 miles from Foster City, 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...
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Director 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 Director of Regulatory Affairs position
- Clinical Research
- Biology
- Immunology
- Assay Development
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Institutional Review Board
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- GxP
- ISO 13485
- Change Control
- Microbiology
- Medical Device Sales
- Product Launch
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Diagnostic
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Process Improvement
- Military Background
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Reporting
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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