Director of Regulatory Affairs Jobs in California
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.
Executive Director of Regulatory Affairs Live What you will do Lets do this. Lets change the world....
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
- 1 day ago
- San Mateo, CA
- 1 day 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
- 5 days ago
- Brisbane, CA
- 5 days ago
Associate) Director/Senior Director, Regulatory Affairs, Therapeutics in Brisbane Job Ref: ......
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The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes...
The Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Brisbane, CA
- 9 days ago
- Brisbane, CA
- 9 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...
Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management....
Sr Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair (on-site)
- Santa Clara, CA
- 12 days ago
- Santa Clara, 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
- 13 days ago
- Santa Clara, 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
- 14 days ago
- Pleasanton, CA
- 14 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...
We are building a next-generation precision medicine company focused on immunology and inflammation.The company's Mirador360 precision development engine leverages the latest advances in human...
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA
- 16 days ago
- Palo Alto, CA
- 16 days ago
Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team....
Systems, and import/export requirements Experience as the RA representative on project core teams Strong communication and teamwork skills Ability to lead multiple projects and meet deadlines Capacity...
Director, Regulatory Affairs Class III Device
- Santa Clarita, CA
- 18 days ago
- Santa Clarita, CA
- 18 days ago
Kelly Science & Clinical is seeking a hybrid Director, Regulatory Affairs for a direct hire position at a leading client in Valencia, CA....
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Highest Education Level
Director of Regulatory Affairss in California 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
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- 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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