Director of Regulatory Affairs Jobs in Alameda, CA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Senior Director, Regulatory Affairs (Oncology)
- Exelixis
- Alameda, CA
- 17 hours ago
- Alameda, CA
- 17 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 PersonManager, Regulatory Affairs CMC
- 1010 Gilead Sciences, Inc.
- Foster City, CA (15 miles from Alameda, CA)
- 6 days ago
- Foster City, CA (15 miles from Alameda, 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 (15 miles from Alameda, CA)
- 6 days ago
- Foster City, CA (15 miles from Alameda, CA)
- 6 days ago
This role will report to the Director, Global Regulatory Affairs Advertising and Promotion....
HybridManager, Regulatory Affairs CMC
- Gilead Sciences
- Foster City, CA (15 miles from Alameda, CA)
- 8 days ago
- Foster City, CA (15 miles from Alameda, 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 (21 miles from Alameda, CA)
- 10 days ago
- Redwood City, CA (21 miles from Alameda, 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 Role...
RemoteAssociate Director, Regulatory Affairs Project Planning & Coordination
- ACADIA Pharmaceuticals Inc.
- South San Francisco, CA (11 miles from Alameda, CA)
- 10 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 10 days ago
Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate...
HybridDirector, Regulatory Affairs & Market Development
- WeaveGrid
- San Francisco, CA (7 miles from Alameda, CA)
- 11 days ago
- San Francisco, CA (7 miles from Alameda, 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 Person- BridgeBio Pharma, Inc.
- San Francisco, CA (7 miles from Alameda, CA)
- 12 days ago
- San Francisco, CA (7 miles from Alameda, 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
- 19 days ago
- Alameda, CA
- 19 days ago
The Opportunity This Associate Director Regulatory Affairs will work on-site out of our Alameda, CA location in the Diabetes Care Division....
In PersonAssociate Director, Regulatory Affairs
- Maze Therapeutics
- South San Francisco, CA (11 miles from Alameda, CA)
- 21 days ago
- South San Francisco, CA (11 miles from Alameda, 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 and...
HybridSenior Director, Regulatory Affairs (Strategy, Hematology Oncology)
- Nurix Therapeutics
- Brisbane, CA (9 miles from Alameda, CA)
- 22 days ago
- Brisbane, CA (9 miles from Alameda, CA)
- 22 days ago
Job Summary: Nurix Therapeutics, Inc. is seeking a Senior Director Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team....
In PersonAssociate Director, Regulatory Affairs (Strategy, Hematology Oncology)
- Nurix Therapeutics, Inc.
- Brisbane, CA (9 miles from Alameda, CA)
- 25 days ago
- Brisbane, CA (9 miles from Alameda, CA)
- 25 days ago
Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team....
In Person- Revolution Medicines
- Redwood City, CA (21 miles from Alameda, CA)
- 27 days ago
- Redwood City, CA (21 miles from Alameda, 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 (11 miles from Alameda, CA)
- 30+ days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 30+ days ago
About the role: Allogene is seeking an Associate Director, Regulatory Affairs within the Global Regulatory Affairs and Clinical Quality organization who will manage worldwide interactions and negotiations...
HybridDemographic Data for Alameda, CA
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Director of Regulatory Affairss in Alameda, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director 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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