Top 1021 contributor 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
Principal Integration & Data Platform Engineer
Younger Optics —Torrance, CA
- $125,000 - $140,000 a year
- Full-time
- Hybrid work
- Background check
- Azure
- System design
- Health insurance
- Dental insurance
Quick Apply
Senior Information Security Lead
Genesis Capital LLC —Sherman Oaks, CA
- $125,000 - $165,000 a year
- Full-time
- Computer science
- 7 years
- Azure
- Health savings account
- Health insurance
Quick Apply
Fashion Designer for Jr and young contemporary
Elizon apparel LLC —Alhambra, CA
- $45 - $60 an hour
- Full-time
- Background check
- Merchandising
- Research
- Relocation assistance
Quick Apply
3d
Territory Manager
Frontline Wildfire Defense —Los Angeles, CA
- From $100,000 a year
- Full-time
- Google Workspace
- Mid-level
- 3 years
- Travel reimbursement
- Paid training
Quick Apply
Senior Analytics Engineer
Motion Picture Industry Pension & Health Plans —Los Angeles, CA
- $125,000 - $145,000 a year
- Extended hours
- Hybrid work
- 7 years
- Computer Science
- HIPAA
- Health insurance
- Dental insurance
Quick Apply
Sales Representative
FUZE Technology —Los Angeles, CA
- $250 - $5,000 a month
- Choose your own hours
- Hospitality
- No background check
- Entry level
- Work from home
- Flexible schedule
Quick Apply
Homecare Sales & Marketing Executive
Care To Stay Home Santa Ana —Burbank, CA
- $90,000 - $110,000 a year
- Customer service
- Mid-level
- 3 years
Quick Apply
Business Development Sales Representative - New Accounts
Deluxe Photo Inc. —Los Angeles, CA
- $5,000 - $10,000 a month
- Part-time
- CRM software
- Sales
- No background check
Quick Apply
Photo Director
Profiles —Los Angeles, CA
- $150,000 a year
- Full-time
- Office
- 8 years
- Senior level
Quick Apply
Freelance Writer/Contributor
HiConsumption —Los Angeles, CA
- Part-time
- Remote
- English
- Research
- Entry level
Frontend Engineer
Capsule —Los Angeles, CA
- $100,000 - $170,000 a year
- Full-time
- Hybrid work
- Mid-level
- 4 years
- Communication skills
- Health insurance
- Dental insurance
Seasonal Sales Associate, West Hollywood (Part-Time)
Away —West Hollywood, CA
- $23 an hour
- Temporary
- In-person
- Ability to stand for extended periods
- Ability to lift 25 pounds
9d
Education and Development Parent Educator
Bright Horizons —Burbank, CA
- $28.85 - $38.46 an hour
- Part-time
- Remote
- Computer literacy
- Public speaking
- Research
- Tuition reimbursement
Quick Apply
7d
Customer Experience Manager
GigXR —Los Angeles, CA
- $60,000 - $120,000 a year
- Hybrid work
- Up to 50% travel
- Mid-level
- 3 years
Live Blog Editor (Remote)
The Associated Press —Los Angeles, CA
- $53,477 - $85,214 a year
- Weekends as needed
- Remote
- Mid-level
- 3 years
- Bachelor's degree
- Paid parental leave
- Paid holidays
8d
Manager of Content & Editorial (On-Site)
UCLA Health —Los Angeles, CA
- $95,400 - $208,300 a year
- 7 years
- Management
- Marketing
Human Resources Specialist I
Los Angeles Unified School District —Los Angeles, CA
- $76,910 - $94,050 a year
- Online Application
- Data analysis skills
- Driver's License
- Bachelor's degree
- Paid holidays
- Health insurance
8d
Manager, Visual Merchandising & Store Design Operations
Hourglass Cosmetics —Los Angeles, CA
- $90,000 - $98,000 a year
- Hybrid work
- 5 years
- Bachelor of Science
- Office
Quick Apply
Data Contributor
TELUS Digital —Glendale, CA
- $250 - $375 a day
- Temporary
- English
- US work authorization
- In-person
- Referral program
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

contributor jobs in los angeles, ca

FDA Submissions Specialist

Principal Integration & Data Platform Engineer

Senior Information Security Lead

Fashion Designer for Jr and young contemporary

Territory Manager

Senior Analytics Engineer

Sales Representative

Homecare Sales & Marketing Executive

Business Development Sales Representative - New Accounts

Photo Director

Freelance Writer/Contributor

Frontend Engineer

Seasonal Sales Associate, West Hollywood (Part-Time)

Education and Development Parent Educator

Customer Experience Manager

Live Blog Editor (Remote)

Manager of Content & Editorial (On-Site)

Human Resources Specialist I

Manager, Visual Merchandising & Store Design Operations

Data Contributor

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

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