Manager of Regulatory Affairs Jobs in South San Francisco, 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.
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (11 miles from South San Francisco, CA)
- 9 days ago
- Alameda, CA (11 miles from South San Francisco, CA)
- 9 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 (11 miles from South San Francisco, CA)
- 30+ days ago
- Alameda, CA (11 miles from South San Francisco, CA)
- 30+ 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 Manager, Regulatory Affairs
- San Francisco, CA (8 miles from South San Francisco, CA)
- 9 hours ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 9 hours ago
About the Role Chime is seeking a Senior Manager of Regulatory Affairs to join our Legal and Compliance function....
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (11 miles from South San Francisco, CA)
- 1 day ago
- Alameda, CA (11 miles from South San Francisco, CA)
- 1 day 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...
Manager, Regulatory Affairs-Document Coordinator
- San Francisco, CA (8 miles from South San Francisco, CA)
- 7 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 7 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...
Associate Director, Regulatory Affairs
- Redwood City, CA (16 miles from South San Francisco, CA)
- 8 days ago
- Redwood City, CA (16 miles from South San Francisco, CA)
- 8 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...
Sr Director, Regulatory Affairs CMC
- Foster City, CA (11 miles from South San Francisco, CA)
- 8 days ago
- Foster City, CA (11 miles from South San Francisco, CA)
- 8 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...
Regulatory Affairs Manager - Canada & Latin America - Diabetes Care (on-site)
- Alameda, CA (11 miles from South San Francisco, CA)
- 8 days ago
- Alameda, CA (11 miles from South San Francisco, CA)
- 8 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 (11 miles from South San Francisco, CA)
- 8 days ago
- Alameda, CA (11 miles from South San Francisco, CA)
- 8 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
- 9 days ago
- South San Francisco, CA
- 9 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...
Senior Director, Regulatory Affairs
- South San Francisco, CA
- 9 days ago
- South San Francisco, CA
- 9 days ago
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle...
Director, Regulatory Affairs - Labeling
- San Francisco, CA (8 miles from South San Francisco, CA)
- 9 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 9 days ago
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...
Director, Regulatory Affairs and Quality Assurance
- San Francisco, CA (8 miles from South San Francisco, CA)
- 14 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 14 days ago
Ensure an effective Quality Management System (QMS). This is a remote US role....
Remote Work- San Francisco, CA (8 miles from South San Francisco, CA)
- 15 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 15 days ago
THE COMPANY 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal...
Manager, Regulatory Affairs Advertising and Promotion
- Foster City, CA (11 miles from South San Francisco, CA)
- 17 days ago
- Foster City, CA (11 miles from South San Francisco, CA)
- 17 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....
Demographic Data for South San Francisco, CA
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Salary for Manager of Regulatory Affairs Jobs in South San Francisco, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in South San Francisco, 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
- Biochemistry
- Biology
- Immunology
- 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
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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