Manager of Regulatory Affairs 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
- Dendreon Pharmaceuticals LLC
- Seal Beach, CA
- 6 hours ago
- Seal Beach, CA
- 6 hours ago
Overview Who We Are: At Dendreon, were transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved...
In PersonSenior Director, Regulatory Affairs (Oncology)
- Exelixis
- Alameda, CA
- 13 hours ago
- Alameda, CA
- 13 hours ago
SUMMARY/JOB PURPOSE: Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements....
In PersonRegulatory Affairs Manager Vascular (on-site)
- Abbott Laboratories
- Santa Clara, CA
- 14 hours ago
- Santa Clara, CA
- 14 hours ago
PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions Experience with Class II and Class III medical devices Ability to define regulatory strategy....
In PersonDirector of Regulatory Affairs
- Radiant Nuclear
- El Segundo, CA
- 17 hours ago
- El Segundo, CA
- 17 hours ago
About Radiant Radiant is an El Segundo, CA-based startup building the world's first mass-produced, portable nuclear microreactors. The company's first reactor, Kaleidos, is a 1-megawatt, fail-safe...
In PersonRegulatory Affairs Manager ABODE COMMUNITIES - 3.2 Los Angeles, CA Job Details Full-time $90,000 - $103,000 a year 16 hours ago Qualifications Stakeholder relationship building Full Job...
In PersonDirector, Regulatory Affairs Devices and Combination Products
- AbbVie, Inc
- Irvine, CA
- 5 days ago
- Irvine, CA
- 5 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...
In PersonAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued,...
In PersonDirector, Regulatory Affairs CMC
- Kite Pharma
- Santa Monica, CA
- 6 days ago
- Santa Monica, CA
- 6 days ago
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible...
In PersonManager, Regulatory Affairs CMC
- 1010 Gilead Sciences, Inc.
- Foster City, CA
- 6 days ago
- Foster City, CA
- 6 days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
In PersonAssociate 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...
HybridManager, Regulatory Affairs CMC
- Gilead Sciences
- Foster City, CA
- 8 days ago
- Foster City, 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...
In PersonDirector, 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...
HybridDirector, Regulatory Affairs & Market Development
- WeaveGrid
- San Francisco, CA
- 11 days ago
- San Francisco, CA
- 11 days ago
About the Role In this role, you will help accelerate the adoption of utility EV managed charging and virtual power plant programs by shaping the regulatory, policy, and market conditions that...
In PersonRegulatory Affairs Manager Diabetes Care (on-site)
- Abbott
- Alameda, CA
- 12 days ago
- Alameda, CA
- 12 days ago
Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities....
In PersonDemographic Data for California
Moving to California? Find some basic demographic data about California below.
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
- ICH Guidelines
- Good Laboratory Practice
- 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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