Director of Regulatory Affairs Jobs in Menlo Park, 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.
- Alameda, CA (22 miles from Menlo Park, CA)
- 2 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 2 days ago
The Opportunity The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or...
Associate Director, Regulatory Affairs
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 5 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 5 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 (3 miles from Menlo Park, CA)
- 9 days ago
- Redwood City, CA (3 miles from Menlo Park, CA)
- 9 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 (3 miles from Menlo Park, CA)
- 9 days ago
- Redwood City, CA (3 miles from Menlo Park, 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...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 10 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 10 days ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA (8 miles from Menlo Park, CA)
- 11 days ago
- Foster City, CA (8 miles from Menlo Park, CA)
- 11 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- Redwood City, CA (3 miles from Menlo Park, CA)
- 11 days ago
- Redwood City, CA (3 miles from Menlo Park, CA)
- 11 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
- 16 days ago
- Menlo Park, 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...
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...
Manager, Regulatory Affairs Strategy
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 20 days ago
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 20 days ago
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 (10 miles from Menlo Park, CA)
- 22 days ago
- Sunnyvale, CA (10 miles from Menlo Park, 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 - International Compliance Operations - Diabetes Care (on-site)
- Alameda, CA (22 miles from Menlo Park, CA)
- 29 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 29 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-CMC
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 30+ days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 30+ days ago
The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs....
Associate Director Regulatory Affairs - APAC - Diabetes Care
- Alameda, CA (22 miles from Menlo Park, CA)
- 90+ days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 90+ days ago
The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our Alameda, CA, location in the Diabetes Division....
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 90+ days ago
- Pleasanton, CA (22 miles from Menlo Park, 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...
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Director of Regulatory Affairss in Menlo Park, 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
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- 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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