Manager of Regulatory Affairs Jobs in Santa Clara, 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.
We are seeking a highly skilled and proactive Regulatory Affairs Consultant to support our clinical-stage regulatory programs. Preference will be given to candidates based on or comfortable...
Regulatory Affairs Manager - Heart Failure
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 2 days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 2 days ago
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to: Career development with...
Associate Director, Regulatory Affairs - Labeling Management
- San Jose, CA (3 miles from Santa Clara, CA)
- 6 days ago
- San Jose, CA (3 miles from Santa Clara, CA)
- 6 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Associate Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 9 days ago
- Redwood City, CA (17 miles from Santa Clara, 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...
Sr Director, Regulatory Affairs CMC
- Foster City, CA (22 miles from Santa Clara, CA)
- 9 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 9 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, Regulatory Affairs Advertising and Promotion
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 18 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....
- Redwood City, CA (17 miles from Santa Clara, CA)
- 18 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 18 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...
Director, Regulatory Affairs CMC
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
Provides regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises....
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ 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 Vascular (on-site)
- Santa Clara, CA
- 90+ days ago
- Santa Clara, 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...
Associate Director, Regulatory Affairs
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ 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...
Demographic Data for Santa Clara, CA
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Salary for Manager of Regulatory Affairs Jobs in Santa Clara, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Santa Clara, 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
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Good Manufacturing Practices
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Process Improvement
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- 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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