... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
... on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role ...
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School o
Claremont, CA · On-site
$2.5K - $15K/mo
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School of Applied Life Sciences Position Overview The primary responsibilities of the Adjunct Faculty ...
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School o
Claremont, CA · On-site
$2.5K - $15K/mo
Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School of Applied Life Sciences Position Overview The primary responsibilities of the Adjunct Faculty ...
Senior Regulatory Affairs Specialist
Palo Alto, CA · On-site +1
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system-the first FDA-cleared, portable, ultra-low-field ...
Senior Regulatory Affairs Specialist
Palo Alto, CA · On-site +1
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system-the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system--the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system--the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop system-the first FDA-cleared, portable, ultra-low-field ...
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop system-the first FDA-cleared, portable, ultra-low-field ...
Director of Quality Assurance
San Francisco, CA · On-site
$150 - $190/hr
Expert knowledge of US FDA regulatory requirements, including cGMP, GLP, GCP, GVP, QMSR, and ISO standards * Experience applying risk management principles to decision making * Experience engaging ...
Director of Quality Assurance
San Francisco, CA · On-site
$150 - $190/hr
Expert knowledge of US FDA regulatory requirements, including cGMP, GLP, GCP, GVP, QMSR, and ISO standards * Experience applying risk management principles to decision making * Experience engaging ...
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Quick apply
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Director of Quality Assurance
San Francisco, CA · On-site
$180 - $260/hr
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Director of Quality Assurance
San Francisco, CA · On-site
$180 - $260/hr
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Director of Quality Assurance
San Francisco, CA · On-site
$200K - $215K/yr
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Director of Quality Assurance
San Francisco, CA · On-site
$200K - $215K/yr
Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. * Create, maintain, review, and approve GXP ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$204 - $378/hr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$204 - $378/hr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$204 - $378/hr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$204 - $378/hr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$203K - $378K/yr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$203K - $378K/yr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$203K - $378K/yr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Corporate Counsel, Global TechOps & Pharma Quality
South San Francisco, CA · On-site
$203K - $378K/yr
Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. * Partnering with PT Quality organization to address critical ...
Senior Regulatory Affairs Specialist
San Jose, CA · On-site
$149 - $175/hr
... US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspectiveExecute US FDA 510(k) and Technical File creation and remediation, collaborating with ...
Senior Regulatory Affairs Specialist
San Jose, CA · On-site
$149 - $175/hr
... US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspectiveExecute US FDA 510(k) and Technical File creation and remediation, collaborating with ...
Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective * Execute US FDA 510(k) and Technical File creation and remediation ...
Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective * Execute US FDA 510(k) and Technical File creation and remediation ...
Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective * Execute US FDA 510(k) and Technical File creation and remediation ...
Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective * Execute US FDA 510(k) and Technical File creation and remediation ...
Senior Software Quality Engineer
San Francisco, CA · On-site
$180 - $240/hr
Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA QMSR, ISO 13485, IEC 62304, and IEC 62366-1 and other relevant standards. * Support the product ...
Senior Software Quality Engineer
San Francisco, CA · On-site
$180 - $240/hr
Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA QMSR, ISO 13485, IEC 62304, and IEC 62366-1 and other relevant standards. * Support the product ...
They're currently seeking a Regulatory Affairs Specialist/Senior Specialist who will be responsible for preparing and filing complex pre-market and post-market regulatory submissions with the US FDA ...
They're currently seeking a Regulatory Affairs Specialist/Senior Specialist who will be responsible for preparing and filing complex pre-market and post-market regulatory submissions with the US FDA ...
Us Fda information
See California salary details
$9.65 - $15.77
9% of jobs
$21.41 is the 25th percentile. Wages below this are outliers.
$15.77 - $21.89
17% of jobs
$21.89 - $28.01
17% of jobs
The median wage is $31.63 / hr.
$28.01 - $34.13
12% of jobs
$34.13 - $40.25
11% of jobs
$40.25 - $46.37
9% of jobs
$46.54 is the 75th percentile. Wages above this are outliers.
$46.37 - $52.49
9% of jobs
$52.49 - $58.61
6% of jobs
$58.61 - $64.73
4% of jobs
$64.73 - $70.85
3% of jobs
$70.85 - $76.97
2% of jobs
$9
$37
$76
How much do us fda jobs pay per hour?
What is the US FDA?
What are the key skills and qualifications needed to thrive as a US FDA Regulatory Affairs Specialist?
What are some common challenges faced by professionals working in roles related to the US FDA?
What is the difference between Us Fda vs Us Pharmacist?
| Aspect | Us Fda | Us Pharmacist |
|---|---|---|
| Required Credentials | Regulatory knowledge, possibly a degree in health sciences | Doctor of Pharmacy (PharmD), state licensure |
| Work Environment | Regulatory agencies, laboratories, compliance offices | Pharmacies, hospitals, clinics |
| Industry Usage | Regulatory oversight, policy development | Patient care, medication dispensing |
| Common Search/Comparison | Regulatory roles, compliance jobs | Clinical roles, medication management |
The main difference is that Us Fda professionals focus on regulation, compliance, and policy within the healthcare industry, often working for government agencies. In contrast, Us Pharmacists are healthcare providers directly involved in patient care and medication dispensing. While both roles require healthcare knowledge, their work environments and responsibilities differ significantly.
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Senior Director / Executive Director, US Regulatory Strategy
San Francisco, CA
Full-time
Re-posted yesterday
Job description
We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology and pharmaceutical clients developing innovative and complex therapies.Â
The successful candidate will serve as a trusted strategic advisor to clients pursuing late-stage development and commercialization of complex biologics, such as combination products, with a particular emphasis on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable.Â
In addition to technical regulatory leadership, this role requires strong client-facing skills, business acumen, and the ability to contribute to the growth of a boutique consultancy through thought leadership, client development, and industry engagement.Â
Key ResponsibilitiesÂ
Regulatory Strategy LeadershipÂ
Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management.Â
Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics.Â
Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy.Â
Lead all aspects of health authority interactions
Support regulatory due diligence activities.Â
Experience with EMA and other international health authorities is highly valued.Â
Client Leadership and ConsultingÂ
Serve as a senior strategic advisor and primary client contact.Â
Build long-term biotech and pharmaceutical client relationships.Â
Lead multidisciplinary consulting teams and mentor junior staff.Â
Deliver high-quality regulatory recommendations, reports, and presentations.Â
Business Development and GrowthÂ
Support business development, proposals, and client pitches.Â
Represent the organization at conferences and industry events.Â
Develop thought leadership materials and support company growth.Â
Requirements
Required QualificationsÂ
Degree in a life sciences disciplineÂ
Significant industry experienceÂ
Deep expertise in US FDA regulatory strategy for biologics.Â
Multiple successful BLA experiences with direct FDA interactions.Â
 Significant experience with complex modalities, such as combination products and cell and gene therapiesÂ
Strong consulting, leadership, communication, and presentation skills.Â