Top 4851 Program specialist Jobs in Santa Monica, Ca

FDA Submissions Specialist
Confidential Healthcare Company —Los Angeles, CA
- $30 - $45 an hour
- Full-time
- Hybrid work
- 5 years
- Writing skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
Property Supervisor
Menorah Housing Foundation —Los Angeles, CA
- $70,000 - $90,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
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Early Care and Education Mental Health Consultant
Allies for Every Child —Culver City, CA
- $71,500 - $77,000 a year
- Email
- Classroom
- Spanish
- Microsoft Outlook
- Paid jury duty
- Health savings account
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Probation Officer
COUNTY OF LOS ANGELES PROBATION DEPARTMENT —Los Angeles, CA
- $65,430 - $83,515 a year
- Online Application
- Residential
- 21 years or older
- Bachelor's degree
- Health savings account
- Paid holidays
Polestar Sales Specialist
Galpin Motors —Beverly Hills, CA
- From $25 an hour
- Full-time
- Sales
- Dealership
- Mid-level
- Health savings account
- Health insurance
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Specialist: Seasonal, Part-time
Apple —Santa Monica, CA
- $24.00 - $29.99 an hour
- Part-time
- Entry level
- Employee stock purchase plan
- Health insurance
Museum Experience Facilitator (Seasonal)
Cayton Children's Museum —Santa Monica, CA
- $23 - $25 an hour
- Part-time
- Spanish
- Sales
- English
Quick Apply
Sales Representative – Biotech (Entry)
Immune Biopharma —Beverly Hills, CA
- $88,556 - $118,356 a year
- Online Application
- No travel
- Leadership
- Communication skills
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Inpatient/ Primary Care Physician
Kedren Community Health Center Inc —Los Angeles, CA
- $185,000 a year
- On call
- CPR Certification
- Medicine
- BLS Certification
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Primary Care Physician – Outpatient
LA County Department of Health Services, High Desert Regional Health Center Group —Los Angeles, CA
- $252,830.88 - $338,987.88 a year
- Full-time
- Spanish
- Medicine
- Doctoral degree
- Health savings account
- Paid holidays
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Physical Therapist - Home Health
CA Rehab & Physical Therapy Specialists —Los Angeles, CA
- $90 an hour
- Part-time
- CPR Certification
- Doctoral degree
- BLS Certification
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6d
Physician
South Central Family Health Cent —Los Angeles, CA
- $224,800 - $244,000 a year
- Full-time
- Spanish
- CPR Certification
- Medicine
- Health insurance
- Dental insurance
Quick Apply
Credentialed Middle School Special Education Teacher (2025-2026 school year)
New West Charter School —Los Angeles, CA
- $68,473 - $100,951 a year
- Full-time
- Classroom
- Google Workspace
- Management
- Health insurance
- Dental insurance
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Bridal Seamstress/Tailor- Wedding Gown Specialist
Fazio Inc —Los Angeles, CA
- $25 - $30 an hour
- Full-time
- Customer service
- Basic math
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Speech Language Pathologist (SLP) - Schools Based
Supplemental Health Care —Los Angeles, CA
- $61 - $66 an hour
- Full-time
- School experience
- Classroom
- Military encouraged
- Continuing education credits
- Health savings account
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12d
Wildlife Biologist (Southern California)
SummitWest Environmental —Los Angeles, CA
- $23 - $45 an hour
- Part-time
- Microsoft Word
- Background check
- Construction site
- Paid training
- Health insurance
Quick Apply
Associate Clinical Director (RN, NP, or PA) - Oncology
Artemis —Santa Monica, CA
- $120,000 - $160,000 a year
- Email
- Private practice
- RN License
- In-person
- Health insurance
- Dental insurance
Quick Apply
1d
Engineering and Environmental Sciences Project Manager/Sr.-Level Engineer
Citadel EHS —Signal Hill, CA
- $100,000 - $150,000 a year
- Weekends as needed
- Microsoft Word
- Background check
- Bachelor of Science
- Health savings account
- Relocation assistance
Quick Apply
13d
BCBA (Behavior Consultant- Adults with Developmental Disabilities)
Paul Boyle, Psychology, Inc. —Los Angeles County, CA
- $55 - $68 an hour
- Part-time
- Hybrid work
- Management
- Adults
- Mid-level
- Mileage reimbursement
- 401(k)
Quick Apply
2d
E-commerce & Marketplace Brand Specialist
Great Eastern Entertainment —Compton, CA
- $25 - $30 an hour
- Full-time
- 3 years
- Analysis skills
- Mentoring
- Health insurance
- Dental insurance
Quick Apply

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FDA Submissions Specialist

Confidential Healthcare Company
Los Angeles, CA

Quick Apply

Job Details

Full-time
$30 - $45 an hour

Benefits

Health insurance
Dental insurance
Paid time off
Vision insurance

Qualifications

Writing skills
FDA 21 CFR Part 11
GMP
Laboratory regulatory affairs
Attention to detail
Master of Science
ICH Q10
Chemistry, manufacturing & controls
Biomedical regulatory compliance
Clinical quality assurance standards
Internal audits

Full Job Description

The Opportunity

We are seeking a seasoned FDA Submissions Specialist who brings deep, hands-on expertise in navigating the full spectrum of FDA submission processes. This is not an advisory role — we need someone who has personally led and authored regulatory submissions, understands the intricacies of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP), and can serve as a strategic regulatory partner across the organization. You will take direct ownership of our submission pipeline, drive regulatory strategy from early development through approval, and be the internal authority on FDA requirements, pathways, and evolving guidance.

Non-Negotiable Requirement

Candidates must have direct, hands-on experience preparing and submitting at least one of the following to the FDA: 510(k), IND, BLA, NDA or PMA. Advisory or supporting roles do not meet this requirement — we are looking for individuals who served as core contributors to the submission itself.

What You’ll Do

Lead the end-to-end preparation, assembly, and submission of FDA applications — including 510(k)s, INDs, BLAs, and PMAs — from initial planning through agency receipt, ensuring completeness, accuracy, and strategic framing at every step.
Manage the full lifecycle of active submissions, including amendments, supplements, annual reports, and responses to FDA information requests or deficiency letters.
Author and review responses to FDA information requests, deficiency letters, Complete Response Letters (CRLs), and Refuse-to-File (RTF) notifications with clarity and technical precision.
Serve as the primary point of contact for FDA interactions — preparing meeting requests, briefing documents, and written responses, and representing the company during agency communications.
Develop and own regulatory strategy for pipeline programs, assessing submission pathways, identifying risks early, and advising leadership on optimal routes to approval.
Advise leadership and cross-functional stakeholders on regulatory requirements, timelines, and strategic options to support program decisions.
Ensure ongoing inspection readiness by maintaining robust regulatory compliance across all processes, documentation, and activities per 21 CFR Parts 11, 50, 54, 56, 58, 210/211, 312, 314, 600-series, 820, and applicable ICH guidelines (E6, Q8-Q10).
Support internal audits, CAPA development, and gap assessments aligned with GLP, GMP, and GCP standards.
Collaborate cross-functionally with Clinical Operations, Medical Affairs, R&D, and Quality to align regulatory requirements with program timelines and deliverables.
Provide regulatory support for Chemistry, Manufacturing, and Controls (CMC) sections of INDs, BLAs, NDAs, and supplements, including review of drug substance and drug product specifications, stability data, and manufacturing process descriptions.
Support regulatory strategy for CMC development milestones, including IND- enabling studies, Phase 2/3 manufacturing scale-up, and BLA/NDA readiness assessments aligned with ICH Q8, Q9, Q10, and Q11 guidelines.
Provide regulatory training and guidance to internal teams on submission requirements, compliance obligations, and agency expectations.

What You’ll Bring

Education & Experience

Bachelor’s degree in a scientific or engineering discipline; advanced degree (M.S., Ph.D., Pharm.D., RAC) strongly preferred.
5+ years of FDA regulatory affairs experience in biotech, pharma, or medical devices, with verifiable, hands-on submission authorship.
Direct experience with one or more submission types: 510(k), IND, BLA, or PMA — from drafting through submission and agency follow-up.
Experience with both drug/biologic and device regulatory pathways is a strong differentiator.

Skills and Attributes

Deep command of 21 CFR Parts 50, 54, 56, 58, 210/211, 312, 314, 600-series, and 820, as well as ICH guidelines (E6 GCP, Q8-Q10 pharmaceutical development, and M4 CTD format).
Familiarity with eCTD structure and electronic submission requirements via the FDA Electronic Submissions Gateway (ESG).
Understanding of nonclinical study designs (GLP toxicology, pharmacology) andtheir regulatory significance for IND/NDA/BLA filings.
Ability to clearly communicate complex regulatory requirements to both technical and non-technical stakeholders, including senior leadership.
Highly organized and detail-oriented, with the ability to manage multiple submissions and priorities simultaneously in a fast-paced environment.
Hybrid role but MUST be based out of Los Angeles, CA.

Benefits:

Competitive salary: $27-45 an hour
Comprehensive health benefits package including medical, dental, and vision insurance.

Job Type: Full-time

Pay: $30.00 - $45.00 per hour

Benefits:

Dental insurance
Health insurance
Paid time off
Vision insurance

Work Location: Hybrid remote in Los Angeles, CA 90066

Quick Apply

Refine Your Search

program specialist jobs in santa monica, ca

FDA Submissions Specialist

Property Supervisor

Early Care and Education Mental Health Consultant

Probation Officer

Polestar Sales Specialist

Specialist: Seasonal, Part-time

Museum Experience Facilitator (Seasonal)

Sales Representative – Biotech (Entry)

Inpatient/ Primary Care Physician

Primary Care Physician – Outpatient

Physical Therapist - Home Health

Physician

Credentialed Middle School Special Education Teacher (2025-2026 school year)

Bridal Seamstress/Tailor- Wedding Gown Specialist

Speech Language Pathologist (SLP) - Schools Based

Wildlife Biologist (Southern California)

Associate Clinical Director (RN, NP, or PA) - Oncology

Engineering and Environmental Sciences Project Manager/Sr.-Level Engineer

BCBA (Behavior Consultant- Adults with Developmental Disabilities)

E-commerce & Marketplace Brand Specialist

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