Top 3997 Full remote Jobs in Los Angeles, 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
Geophysicist - AI Trainer
DataAnnotation —Pasadena, CA
- $40 - $60 an hour
- Part-time
- Remote
- Computer Science
- English
- Mid-level
- Flexible schedule
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Full Time Bookkeeper/Bill Pay Coordinator
Bycor, Ltd. —Marina del Rey, CA
- $65,000 a year
- Full-time
- Computer literacy
- Mid-level
- Office
- Paid time off
Quick Apply
13d
Predictive Modeler - AI Trainer
DataAnnotation —Burbank, CA
- $40 - $60 an hour
- Part-time
- Remote
- Computer Science
- English
- Mid-level
- Flexible schedule
Quick Apply
Insurance Risk Management Senior Consultant
FHS Risk Management —Los Angeles, CA
- $115,000 - $140,000 a year
- Full-time
- Hybrid work
- Hospitality
- Mid-level
- Office
- Health insurance
- 401(k)
Quick Apply
Remote Email Support Specialist
Qureos Inc —Los Angeles, CA
- $18 - $27 an hour
- Full-time
- Remote
- Continuous improvement
- Communication skills
- Entry level
2d
Guest Services Agent
UCLA —Los Angeles, CA
- $26.42 - $37.49 an hour
- Overtime
- Hybrid work
- Background check
- 18 years or older
- Writing skills
Branch Coordinator - Remote
Apria Healthcare LLC —Los Angeles, CA
- $20 - $25 an hour
- Full-time
- Remote
- Computer literacy
- Writing skills
- English
- Paid parental leave
- Disability insurance
Quick Apply
Personal Injury Discovery Clerk - REMOTE POSITION
Law Offices of Eslamboly Hakim —Beverly Hills, CA
- $20 - $35 an hour
- Full-time
- Spanish
- English
- Organizational skills
- Health insurance
- Dental insurance
Quick Apply
Supply Chain / Inventory / Production Analyst
That's It Nutrition —Los Angeles, CA
- $70,000 - $90,000 a year
- Full-time
- Mid-level
- Office
- In-person
- Health savings account
- Health insurance
Quick Apply
Executive Assistant
Confidential —Los Angeles, CA
- $75,000 - $95,000 a year
- Full-time
- Google Workspace
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Intake Position
West Los Angeles Law Firm —Los Angeles, CA
- $26 - $30 an hour
- Part-time
- Hybrid work
- Bilingual
- Sales
- In-person
Quick Apply
Aflac Healthcare Benefits Specialist
Aflac —Los Angeles, CA
- $51,699.88 - $80,283.72 a year
- Part-time
- Hybrid work
- Background check
- Customer service
- Presentation skills
- Health insurance
- Opportunities for advancement
Quick Apply
Operations Coordinator / Inside Sales Representative
PASONA N A, INC. —Torrance, CA
- $20 - $30 an hour
- Full-time
- Hybrid work
- Computer literacy
- English
- Office
5d
Account Specialist
GracoRoberts —Carson, CA
- $52,000 - $55,000 a year
- Full-time
- Hybrid work
- Background check
- Customer service
- ERP systems
- Health insurance
- Dental insurance
11d
Patient Services Specialist - Patient Engagement - Full time, Variable, Remote
Providence —Torrance, CA
- $17.56 - $31.52 an hour
- Full-time
- Remote
- Mid-level
- Fair chance
- 1 year
- Paid parental leave
- Paid holidays
8h
Administrative Assistant I
The Metropolitan Water District of Southern California —Los Angeles, CA
- $34.38 - $45.26 an hour
- Full-time
- Hybrid work
- Office
- Administrative experience
- High school diploma or GED
- Dental insurance
- Tuition reimbursement
Word Processor
Allen Matkins —Los Angeles, CA
- $75,000 - $105,000 a year
- Full-time
- Remote
- Microsoft Word
- Background check
- Microsoft Outlook
Calendar Clerk
Goldberg Segalla LLP —Los Angeles, CA
- $17 - $42 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Writing skills
- Health insurance
- Dental insurance
Hybrid Cannabis Budtender/Delivery Driver
California Marijuana Company —Highland Park, CA
- From $19 an hour
- Part-time
- Hybrid work
- Background check
- Clean driving record
- Inventory management
- Employee discount
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

full remote jobs in los angeles, ca

FDA Submissions Specialist

Geophysicist - AI Trainer

Full Time Bookkeeper/Bill Pay Coordinator

Predictive Modeler - AI Trainer

Insurance Risk Management Senior Consultant

Remote Email Support Specialist

Guest Services Agent

Branch Coordinator - Remote

Personal Injury Discovery Clerk - REMOTE POSITION

Supply Chain / Inventory / Production Analyst

Executive Assistant

Intake Position

Aflac Healthcare Benefits Specialist

Operations Coordinator / Inside Sales Representative

Account Specialist

Patient Services Specialist - Patient Engagement - Full time, Variable, Remote

Administrative Assistant I

Word Processor

Calendar Clerk

Hybrid Cannabis Budtender/Delivery Driver

I want to receive the latest job alert for full remote in los angeles, ca

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