Director of Regulatory Affairs Jobs in Pleasanton, 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.
Regulatory Affairs Manager Vascular (on-site)
- Abbott Laboratories
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 18 hours ago
- Santa Clara, CA (21 miles from Pleasanton, CA)
- 18 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 (21 miles from Pleasanton, CA)
- 5 days ago
- Santa Clara, CA (21 miles from Pleasanton, 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 (23 miles from Pleasanton, CA)
- 6 days ago
- Foster City, CA (23 miles from Pleasanton, 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 (23 miles from Pleasanton, CA)
- 6 days ago
- Foster City, CA (23 miles from Pleasanton, 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 (23 miles from Pleasanton, CA)
- 8 days ago
- Foster City, CA (23 miles from Pleasanton, 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 (24 miles from Pleasanton, CA)
- 10 days ago
- Redwood City, CA (24 miles from Pleasanton, 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...
Remote- Revolution Medicines
- Redwood City, CA (24 miles from Pleasanton, CA)
- 27 days ago
- Redwood City, CA (24 miles from Pleasanton, 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...
RemoteSenior Manager, Regulatory Affairs
- Hyperfine Inc
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 45+ days ago
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 45+ days ago
Lead preparation, publishing, and maintenance of regulatory submissions (e.g., FDA 510(k)s, Q-Sub/Pre-Sub interactions as needed, and international registrations such as EU MDR/UKCA, Canada, Australia...
HybridDirector Regulatory Affairs - Cardiac
- Intuitive
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 45+ days ago
- Sunnyvale, CA (19 miles from Pleasanton, CA)
- 45+ days ago
This role is a Director-level Regulatory Affairs leader, who will work with business unit leaders, clinical teams, reimbursement teams to define and execute global cardiac regulatory strategy, leads...
In PersonAssociate Director, Regulatory Affairs CMC
- Gilead Sciences
- Foster City, CA (23 miles from Pleasanton, CA)
- 60+ days ago
- Foster City, CA (23 miles from Pleasanton, CA)
- 60+ days ago
As an Associate Director, CMC Regulatory Affairs for Biologics, at Gilead you will be responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio....
In PersonSenior Manager, Regulatory Affairs
- Revolution Medicines, Inc.
- Redwood City, CA (24 miles from Pleasanton, CA)
- 60+ days ago
- Redwood City, CA (24 miles from Pleasanton, 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...
Hybrid- Revolution Medicines, Inc.
- Redwood City, CA (24 miles from Pleasanton, CA)
- 60+ days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 60+ days ago
The Opportunity: The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed....
HybridDirector, Regulatory Affairs CMC
- Corcept Therapeutics
- Redwood City, CA (24 miles from Pleasanton, CA)
- 90+ days ago
- Redwood City, CA (24 miles from Pleasanton, 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 Pleasanton, CA
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Director of Regulatory Affairss in Pleasanton, 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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