Top 184194 Work Study Jobs

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
Space Subject Matter Expert (Curriculum) — Remote / 1099 — Contingent
Octagon Compliance Group, Inc —Huntsville, AL
- $90 - $120 an hour
- Contract
- Writing skills
- Research
- Master's degree
- Flexible schedule
Quick Apply
4d
Developmental and Stem Cell Biologist
Confidential Posting —San Francisco, CA
- $110,000 - $150,000 a year
- Full-time
- 5 years
- Doctor of Philosophy
- Mentoring
- Health insurance
- Dental insurance
Quick Apply
Clinical and Translational Research Assistant (pre-med)
UB Neurosurgery, Inc —Buffalo, NY
- $17 - $18 an hour
- Full-time
- Bachelor of Science
- Databases
- Bachelor's degree
- Health savings account
- Health insurance
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Child Study Team Professionals-NonPublic Dept.
The Educational Services Commission of New Jersey —Piscataway, NJ
- Up to $375 a day
- Part-time
- Bilingual
- Background check
- School experience
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Clinical Study Data Reviewer
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $60,000 - $74,000 a year
- Remote
- Computer literacy
- Writing skills
- HIPAA
Quick Apply
10d
Data Analyst Assistant - A. Erdynast [Work Study]
Antioch University Santa Barbara —Remote
- Part-time
- Remote
- Research
- University
- Psychology
RA Caribbean Birds - M. Akresh [Work Study]
Antioch University Santa Barbara —Remote
- Part-time
- Remote
- Writing skills
- Organizational skills
- Communication skills
Study Start-up Associate I or II (Remote)
Theradex Oncology —Princeton, NJ
- $60,000 - $105,000 a year
- Full-time
- Remote
- Microsoft Word
- English
- Mid-level
- Disability insurance
- Health insurance
Assistant Research Scientist (Part-Time)
New York University —New York, NY
- $18 an hour
- Part-time
- Remote
- Organizational skills
- Entry level
Senior Clinical Data Manager
Vforce Infotech —Edison, NJ
- $110,000 - $120,000 a year
- Full-time
- Analysis skills
- Bachelor's degree
- Continuous improvement
Quick Apply
Civic Science Fellow - School of Social Science - 18 month appointment
Institute for Advanced Study —Princeton, NJ
- $7,277.77 a month
- Full-time
- Bachelor of Science
- Analysis skills
- University
- Paid holidays
- Disability insurance
Quick Apply
14d
Polygraph Examiner
Central Intelligence Agency —Washington, DC
- $70,506 - $131,826 a year
- Full-time
- Bachelor of Science
- Mid-level
- Residential
Clinical Research Coordinator
Mass Institute of Clinical Research / Ki-Health Partners, LLC —Westborough, MA
- Full-time
- Background check
- Research
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Foreign Language Instructor
Central Intelligence Agency —Washington, DC
- $85,546 - $131,826 a year
- Full-time
- Mid-level
- Education
- Bachelor's degree
- Health insurance
- Dental insurance
Sr. Research Scientist Biophysics
Beacon Hill Life Sciences —South San Francisco, CA
- $68 - $85 an hour
- Full-time
- Doctoral degree
- 3 years
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
13d
Scientist I - Virology
Dawar Consulting, Inc. —Foster City, CA
- $57.50 an hour
- Email
- Pass drug screening
- Mid-level
- Analysis skills
- Paid sick time
Quick Apply
6d
Data Consultant 2 - College of Medicine
Elson S. Floyd College of Medicine, Washington State University —Spokane, WA
- $23.67 - $26.74 an hour
- Temporary
- Background check
- Computer science
- Computer Science
- Flexible schedule
Quick Apply
13d
Research Scientist, Biochemistry
Kaztronix —Wilmington, DE
- Contract
- Master's degree
- Analysis skills
- Doctor of Philosophy
Quick Apply
Scientist III– Cell and Molecular Biology
Astrix Technology Group —Ridgefield, CT
- $48 - $52 an hour
- Contract
- Master's degree
- Analysis skills
- Bachelor's degree
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.

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

Work Study jobs

FDA Submissions Specialist

Space Subject Matter Expert (Curriculum) — Remote / 1099 — Contingent

Developmental and Stem Cell Biologist

Clinical and Translational Research Assistant (pre-med)

Child Study Team Professionals-NonPublic Dept.

Clinical Study Data Reviewer

Data Analyst Assistant - A. Erdynast [Work Study]

RA Caribbean Birds - M. Akresh [Work Study]

Study Start-up Associate I or II (Remote)

Assistant Research Scientist (Part-Time)

Senior Clinical Data Manager

Civic Science Fellow - School of Social Science - 18 month appointment

Polygraph Examiner

Clinical Research Coordinator

Foreign Language Instructor

Sr. Research Scientist Biophysics

Scientist I - Virology

Data Consultant 2 - College of Medicine

Research Scientist, Biochemistry

Scientist III– Cell and Molecular Biology

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