Director of Regulatory Affairs Jobs in Pleasanton, 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.
Sr Manager, Regulatory Affairs
- Redwood City, CA (24 miles from Pleasanton, CA)
- 8 days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 8 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 (24 miles from Pleasanton, CA)
- 9 days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 9 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...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA (23 miles from Pleasanton, CA)
- 10 days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 10 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- Redwood City, CA (24 miles from Pleasanton, CA)
- 10 days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 10 days ago
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 16 days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 16 days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies...
Executive Director, Regulatory Affairs
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 16 days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 16 days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Sr. Manager, Regulatory Affairs
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 22 days ago
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 22 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA
- 90+ days ago
- Pleasanton, CA
- 90+ 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 Global Labeling
- Foster City, CA (23 miles from Pleasanton, CA)
- 26 days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 26 days ago
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...
Manager/Director Regulatory Affairs - Pleasanton, CA (Pleasanton, CA)
- Pleasanton, CA
- 29 days ago
- Pleasanton, CA
- 29 days ago
Collaborate with the quality team to ensure that the companys Quality Management System (QMS) meets regulatory requirements and is effectively implemented....
Senior Manager, Regulatory Affairs
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
- Menlo Park, CA (22 miles from Pleasanton, CA)
- 30+ days ago
Overview of Role: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects...
- Oakland, CA (21 miles from Pleasanton, CA)
- 45+ days ago
- Oakland, CA (21 miles from Pleasanton, CA)
- 45+ days ago
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages...
Associate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products....
Associate Director, Regulatory Affairs
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 45+ days ago
POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization...
Demographic Data for Pleasanton, CA
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Salary for Director of Regulatory Affairs Jobs in Pleasanton, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Pleasanton, 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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