Director of Regulatory Affairs Jobs in Berkeley, 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.
- San Francisco, CA (10 miles from Berkeley, CA)
- 21 hours ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 21 hours ago
Director, Regulatory Affairs, you are a driven global regulatory leader with expertise in regulatory strategy development and execution....
- Alameda, CA (6 miles from Berkeley, CA)
- 1 day ago
- Alameda, CA (6 miles from Berkeley, CA)
- 1 day 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 (16 miles from Berkeley, CA)
- 4 days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 4 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...
Position Summary We are currently seeking an exceptional leader as Director, Regulatory Affairs, to join our team in the mission to restore vision to patients....
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (16 miles from Berkeley, CA)
- 9 days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 9 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 (21 miles from Berkeley, CA)
- 10 days ago
- Foster City, CA (21 miles from Berkeley, CA)
- 10 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 21 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 21 days ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 29 days ago
- Alameda, CA (6 miles from Berkeley, 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 (16 miles from Berkeley, CA)
- 30+ days ago
- South San Francisco, CA (16 miles from Berkeley, 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 (6 miles from Berkeley, CA)
- 90+ days ago
- Alameda, CA (6 miles from Berkeley, 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....
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 26 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 26 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 (21 miles from Berkeley, CA)
- 26 days ago
- Foster City, CA (21 miles from Berkeley, 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...
Director, Regulatory Affairs CMC
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
About the Role >>> Director, Regulatory Affairs CMC As the Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing...
Senior Director Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
Title: Senior Director Regulatory Affairs SUMMARY: A leading biopharmaceutical company is seeking a Sr. Director of Regulatory Affairs....
Manager/Director, Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
A leading innovator in sustainable energy and transportation is seeking a Regulatory Affairs Professional to support its operations in California. This organization is dedicated to accelerating...
Demographic Data for Berkeley, CA
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Salary for Director of Regulatory Affairs Jobs in Berkeley, CA
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Highest Education Level
Director of Regulatory Affairss in Berkeley, 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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