Manager of Regulatory Affairs Remote & Hybrid Only Jobs in California
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.
Associate Director, Regulatory Affairs Advertising and Promotion
- Mirum Pharmaceuticals Inc
- Foster City, CA
- 6 days ago
- Foster City, CA
- 6 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...
HybridDirector, Regulatory Affairs (Clinical)
- Bayside Solutions
- Redwood City, CA
- 10 days ago
- Redwood City, CA
- 10 days ago
Director, Regulatory Affairs (Clinical) in Redwood City, California Overview Director, Regulatory Affairs (Clinical) W2 Contract Pay Rate: $100 - $125 per hour Location: Redwood City, CA - Remote...
RemoteAssociate Director, Regulatory Affairs Project Planning & Coordination
- ACADIA Pharmaceuticals Inc.
- South San Francisco, CA
- 10 days ago
- South San Francisco, CA
- 10 days ago
About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around...
HybridSr. Director, Regulatory Affairs
- BridgeBio Pharma, Inc.
- San Francisco, CA
- 12 days ago
- San Francisco, CA
- 12 days ago
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a...
Remote HybridAssociate Director, Regulatory Affairs
- Maze Therapeutics
- South San Francisco, CA
- 21 days ago
- South San Francisco, CA
- 21 days ago
The Opportunity: 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...
Hybrid- Revolution Medicines
- Redwood City, CA
- 27 days ago
- Redwood City, CA
- 27 days ago
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R D pipeline comprises RAS(ON) inhibitors...
RemoteAssociate Director, Regulatory Affairs
- Allogene Therapeutics, Inc.
- South San Francisco, CA
- 30+ days ago
- South San Francisco, CA
- 30+ days ago
About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell...
HybridSenior Manager, Regulatory Affairs
- Hyperfine Inc
- Palo Alto, CA
- 45+ days ago
- Palo Alto, CA
- 45+ days ago
Learn More About The Role Job Title: Senior Manager, Regulatory Affairs Location: Guilford, CT or Palo Alto, CA (Hybrid, 3 days/week) The Senior Manager, Regulatory Affairs owns and executes U.S. and...
HybridSenior Manager, Regulatory Affairs
- Revolution Medicines, Inc.
- Redwood City, CA
- 60+ days ago
- Redwood City, CA
- 60+ 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...
Hybrid- Revolution Medicines, Inc.
- Redwood City, CA
- 60+ days ago
- Redwood City, CA
- 60+ days ago
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors...
HybridAssociate Director, Regulatory Affairs Advertising & Promotion (Office-based)
- AbbVie, Inc
- Irvine, CA
- 60+ days ago
- Irvine, CA
- 60+ days ago
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of...
HybridAssociate Director, Regulatory Affairs CMC
- Crinetics Pharmaceuticals
- San Diego, CA
- 90+ days ago
- San Diego, CA
- 90+ days ago
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a...
RemoteDirector, Regulatory Affairs CMC
- Corcept Therapeutics
- Redwood City, CA
- 90+ days ago
- Redwood City, CA
- 90+ days ago
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial...
HybridDemographic Data for California
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Manager of Regulatory Affairs Online Courses and Training Opportunities
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Salary for Manager of Regulatory Affairs Jobs in California
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in California 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
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- ICH Guidelines
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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