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.
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA
- 5 hours ago
- Santa Clara, CA
- 5 hours 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 I am looking to speak with Director's of Regulatory Affairs CMC to lead the development and execution of global CMC regulatory strategies for clinical-stage small molecule...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA
- 1 day ago
- Pleasanton, CA
- 1 day 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 / Executive Director of Regulatory Affairs
- Santa Clara, CA
- 2 days ago
- Santa Clara, CA
- 2 days ago
Senior Director / Executive Director of Regulatory Affairs W2 Contract-to-Hire Salary Range: $343,200 - $364,000 per year Location: Redwood City, CA - Hybrid or Remote PST Duties and Responsibilities...
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA
- 3 days ago
- South San Francisco, CA
- 3 days ago
What you'll do: Develop and implement CMC regulatory strategies for investigational and marketed products to ensure successful regulatory submissions and approvals. Author or review CMC sections...
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
- 3 days ago
- Palo Alto, CA
- 3 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...
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Director, Regulatory Affairs Class III Device
- Santa Clarita, CA
- 5 days ago
- Santa Clarita, CA
- 5 days ago
Kelly Science & Clinical is seeking a hybrid Director, Regulatory Affairs for a direct hire position at a leading client in Valencia, CA....
Director Of Regulatory Affairs (San Francisco, Ca)
- San Francisco, CA
- 5 days ago
- San Francisco, CA
- 5 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
- 5 days ago
- San Francisco, CA
- 5 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...
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...
DIRECTOR, REGULATORY AFFAIRS (Hybrid) Job Summary: We are seeking a dedicated and talented Director of Regulatory Affairs to join our team....
Overview Join our exciting team as a Director, Regulatory Affairs!...
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Salary for Director of Regulatory Affairs Jobs in California
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- 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
- Scheduling
- Leadership
- Communication Skills
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