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.
Oversee compliance with global regulatory standards including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR 820, EU MDR 2017/745, TG(MD)R Sch3, RDC ANVISA 665/2022, Japan MHLW 169, CMDR, NRC, BIS, DOT 49 CFR...
Director of Regulatory Affairs Job Description The Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support product development, registration, and...
Director, Regulatory Affairs City : San Diego State : CA Country : US Job Term : Permanent Overview : PharmaLogics Recruiting is seeking a Director, Regulatory Affairs in San Diego, CA....
Maintains a compliant Quality Management System in accordance with: ISO 9001 MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA 21 CFR 820) FDB,...
Remote WorkAssociate Director, Regulatory Affairs - Labeling Management
- San Jose, CA
- 3 days ago
- San Jose, CA
- 3 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Summary #LI-Hybrid #LI-Onsite In this role, you will be a part of the Regulatory team within Navigate and will be primarily responsible for providing strategic product direction as well as...
Manager, Regulatory Affairs-Document Coordinator
- San Francisco, CA
- 5 days ago
- San Francisco, CA
- 5 days ago
regulations (ex-US is a plus) and industry standards pertaining to regulatory Knowledge of the drug development process and eCTD Excellent organization skills and ability to work on multiple projects...
The Opportunity: The Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development...
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Regulatory Affairs Manager - Canada & Latin America - Diabetes Care (on-site)
- Alameda, CA
- 6 days ago
- Alameda, CA
- 6 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...
Commercial Regulatory Affairs Director (Advertising and Promotion)
- Alameda, CA
- 6 days ago
- Alameda, CA
- 6 days ago
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval...
Associate Director, Regulatory Affairs
- South San Francisco, CA
- 7 days ago
- South San Francisco, CA
- 7 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...
Senior Director, Regulatory Affairs
- South San Francisco, CA
- 7 days ago
- South San Francisco, CA
- 7 days ago
This position will report to the Executive Director of Regulatory Affairs....
Regulatory Affairs Manager - APAC - Diabetes Care (on-site)
- Alameda, CA
- 7 days ago
- Alameda, CA
- 7 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...
About the Role >>> Director, Regulatory Labeling As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of...
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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
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Interpersonal Skills
- Reporting
- Collaboration
- Coaching
- Policy Development
- Filing
- Bachelor's Degree
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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