Top 333 Author 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
Test Engineer Level 1/2 (AHT)
Northrop Grumman —Los Angeles, CA
- $69,400 - $125,200 a year
- Overtime
- Microsoft Excel
- Mid-level
- Master's degree
- Paid holidays
- Disability insurance
6d
Associate, Manufacturing
ImmunityBio —Culver City, CA
- $31.25 - $35.00 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Mid-level
- AD&D insurance
- Disability insurance
Archaeologist I
Arcadis —Los Angeles, CA
- $70,304 - $89,424 a year
- Hybrid work
- Construction site
- Ability to walk for extended periods
- Office
- Paid parental leave
- AD&D insurance
Executive Assistant
Delta Solutions & Strategies —Los Angeles AFB, CA
- $120,000 - $150,000 a year
- Full-time
- Mid-level
- 2 years
- Communication skills
- Paid jury duty
- Paid holidays
12d
Sports Education Curriculum Developer
Elevo —Los Angeles, CA
- $71,000 - $80,000 a year
- Full-time
- Research
- Mid-level
- 3 years
- Disability insurance
- Health insurance
Junior Designer
BMW —Santa Monica, CA
- $68,151 - $88,195 a year
- Full-time
- Hybrid work
- Background check
- Pass drug screening
- Office
Lower School Librarian
The Buckley School —Los Angeles, CA
- $65,041 - $134,160 a year
- Part-time
- School experience
- Computer literacy
- Writing skills
- AD&D insurance
- Health insurance
Quick Apply
Pharmaceutical Lab Technician
Siemens Healthineers —Culver City, CA
- $53,400 - $73,425 a year
- Overtime
- Word processing
- Computer literacy
- Mid-level
- Paid training
- Disability insurance
Restaurant Team Member
Shake Shack —Los Angeles, CA
- $20 an hour
- Full-time
- Hospitality
- Fast casual restaurant
- Food service
- Commuter assistance
- Disability insurance
Senior Hazards/Hazardous Materials Analyst
Aspen Environmental Group —California
- $125,000 - $150,000 a year
- Email
- Microsoft Excel
- 11+ years
- Master's degree
Quick Apply
Senior Traffic Analyst
Aspen Environmental Group —California
- $115,000 - $145,000 a year
- Email
- Remote
- Microsoft Excel
- Data analysis skills
- 11+ years
Quick Apply
Sentinel - Mechanical Engineer / Principal Mechanical Engineer - 18778
Northrop Grumman —Redondo Beach, CA
- $72,100 - $155,400 a year
- Overtime
- Microsoft Word
- Microsoft Excel
- Master's degree
- Paid holidays
- Disability insurance
6d
Sr Principal Engineer Systems
Northrop Grumman —Los Angeles, CA
- $142,200 - $213,400 a year
- Overtime
- Bachelor of Science
- Analysis skills
- Bachelor's degree
- Paid holidays
- Disability insurance
Sentinel - Principal / Sr. Principal Mechanical Engineer - 18471
Northrop Grumman —Manhattan Beach, CA
- $89,400 - $193,900 a year
- Overtime
- Microsoft Word
- Microsoft Excel
- Master's degree
- Paid holidays
- Disability insurance
6d
Principal Flight Test Engineer (AHT)
Northrop Grumman —Los Angeles, CA
- $103,600 - $155,400 a year
- Overtime
- Microsoft Excel
- 3 years
- Master's degree
- Paid holidays
- Disability insurance
Senior Aerospace Quality Engineer
Intellisense Systems Inc —Torrance, CA
- $100,000 - $130,000 a year
- Full-time
- 5 years
- Analysis skills
- Travel
- Health savings account
- AD&D insurance
Quick Apply
Material Process Engineering Manager 3 - 18822
Northrop Grumman —Manhattan Beach, CA
- $175,400 - $263,200 a year
- Overtime
- 6 years
- Bachelor of Science
- Engineering
- Paid holidays
- Disability insurance
6d
Staff Systems Engineer
Northrop Grumman —El Segundo, CA
- $177,000 - $265,600 a year
- Overtime
- Military
- Bachelor of Science
- 8 years
- Paid holidays
- Disability insurance
6d
Specialist, Project Engineering 1
L3Harris Technologies —Canoga Park, CA
- $92,500 - $171,500 a year
- Extended hours
- Microsoft Excel
- System design
- Mid-level
- Paid holidays
- Disability insurance

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author jobs near los angeles, ca

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

author jobs in los angeles, ca

FDA Submissions Specialist

Test Engineer Level 1/2 (AHT)

Associate, Manufacturing

Archaeologist I

Executive Assistant

Sports Education Curriculum Developer

Junior Designer

Lower School Librarian

Pharmaceutical Lab Technician

Restaurant Team Member

Senior Hazards/Hazardous Materials Analyst

Senior Traffic Analyst

Sentinel - Mechanical Engineer / Principal Mechanical Engineer - 18778

Sr Principal Engineer Systems

Sentinel - Principal / Sr. Principal Mechanical Engineer - 18471

Principal Flight Test Engineer (AHT)

Senior Aerospace Quality Engineer

Material Process Engineering Manager 3 - 18822

Staff Systems Engineer

Specialist, Project Engineering 1

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