Manager of Regulatory Affairs Jobs in Berkeley, CA
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Director/Sr. Director, Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 5 hours ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 5 hours ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
- 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...
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
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)
- 28 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 28 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
Support product development, manufacturing changes, and quality systems compliance across the product lifecycle....
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
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 Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 25 days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 25 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)
- 25 days ago
- Foster City, CA (21 miles from Berkeley, CA)
- 25 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
Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management....
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. This role involves developing and implementing global...
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 Manager of Regulatory Affairs Jobs in Berkeley, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager 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 Manager 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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