Manager of Regulatory Affairs Jobs in Redwood City, 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.
Senior Director, Regulatory Affairs (Oncology)
- Exelixis
- Alameda, CA (21 miles from Redwood City, CA)
- 19 hours ago
- Alameda, CA (21 miles from Redwood City, CA)
- 19 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 (17 miles from Redwood City, CA)
- 19 hours ago
- Santa Clara, CA (17 miles from Redwood City, CA)
- 19 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 Person- Hoffmann-La Roche Ltd
- Santa Clara, CA (17 miles from Redwood City, CA)
- 5 days ago
- Santa Clara, CA (17 miles from Redwood City, CA)
- 5 days ago
At 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 PersonManager, Regulatory Affairs CMC
- 1010 Gilead Sciences, Inc.
- Foster City, CA (6 miles from Redwood City, CA)
- 6 days ago
- Foster City, CA (6 miles from Redwood 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 miles from Redwood City, CA)
- 6 days ago
- Foster City, CA (6 miles from Redwood 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 (6 miles from Redwood City, CA)
- 8 days ago
- Foster City, CA (6 miles from Redwood 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 (16 miles from Redwood City, CA)
- 10 days ago
- South San Francisco, CA (16 miles from Redwood City, 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 (23 miles from Redwood City, CA)
- 11 days ago
- San Francisco, CA (23 miles from Redwood City, 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 (21 miles from Redwood City, CA)
- 12 days ago
- Alameda, CA (21 miles from Redwood City, 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 PersonSr. Director, Regulatory Affairs
- BridgeBio Pharma, Inc.
- San Francisco, CA (23 miles from Redwood City, CA)
- 12 days ago
- San Francisco, CA (23 miles from Redwood City, 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 (on-site)
- Abbott
- Alameda, CA (21 miles from Redwood City, CA)
- 19 days ago
- Alameda, CA (21 miles from Redwood City, CA)
- 19 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...
In PersonAssociate Director, Regulatory Affairs
- Maze Therapeutics
- South San Francisco, CA (16 miles from Redwood City, CA)
- 21 days ago
- South San Francisco, CA (16 miles from Redwood City, 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...
HybridSenior Director, Regulatory Affairs (Strategy, Hematology Oncology)
- Nurix Therapeutics
- Brisbane, CA (18 miles from Redwood City, CA)
- 22 days ago
- Brisbane, CA (18 miles from Redwood City, CA)
- 22 days ago
Position Title: Senior Director, Regulatory Affairs (Strategy, Hematology Oncology) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and...
In PersonAssociate Director, Regulatory Affairs (Strategy, Hematology Oncology)
- Nurix Therapeutics, Inc.
- Brisbane, CA (18 miles from Redwood City, CA)
- 25 days ago
- Brisbane, CA (18 miles from Redwood City, CA)
- 25 days ago
Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team....
In PersonDemographic Data for Redwood City, CA
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Manager of Regulatory Affairss in Redwood City, 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
- 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
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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