Manager of Regulatory Affairs Jobs in Sunnyvale, 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.
Sr Manager, Regulatory Affairs
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 9 days ago
- Redwood City, CA (13 miles from Sunnyvale, 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 regulate...
Senior Manager, Regulatory Affairs
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 10 days ago
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 10 days ago
The Opportunity: The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA (17 miles from Sunnyvale, CA)
- 11 days ago
- Foster City, CA (17 miles from Sunnyvale, CA)
- 11 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 11 days ago
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 11 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...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 17 days ago
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 17 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...
Executive Director, Regulatory Affairs
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 17 days ago
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 17 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...
Manager, Regulatory Affairs Strategy
- Pleasanton, CA (19 miles from Sunnyvale, CA)
- 20 days ago
- Pleasanton, CA (19 miles from Sunnyvale, 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...
Job Description Primary Function of Position As Senior Manager, Regulatory Affairs, you will lead and manage a team responsible for developing and executing regulatory strategies within the Multiport...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (19 miles from Sunnyvale, CA)
- 90+ days ago
- Pleasanton, CA (19 miles from Sunnyvale, 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 (17 miles from Sunnyvale, CA)
- 27 days ago
- Foster City, CA (17 miles from Sunnyvale, CA)
- 27 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 (19 miles from Sunnyvale, CA)
- 30+ days ago
- Pleasanton, CA (19 miles from Sunnyvale, CA)
- 30+ 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 (10 miles from Sunnyvale, CA)
- 30+ days ago
- Menlo Park, CA (10 miles from Sunnyvale, 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....
Associate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (17 miles from Sunnyvale, CA)
- 45+ days ago
- Foster City, CA (17 miles from Sunnyvale, 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 (17 miles from Sunnyvale, CA)
- 45+ days ago
- Foster City, CA (17 miles from Sunnyvale, CA)
- 45+ days ago
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...
Associate Director, Regulatory Affairs CMC
- Foster City, CA (17 miles from Sunnyvale, CA)
- 60+ days ago
- Foster City, CA (17 miles from Sunnyvale, CA)
- 60+ days ago
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, were creating a healthier world for all people. For more than 35 years,...
Demographic Data for Sunnyvale, CA
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Sunnyvale, 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
- 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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