Top 6921 Program Specialist Job Jobs in Washington, DC

FDA Submissions Specialist
Confidential Healthcare Company —Silver Spring, MD
- $30 - $45 an hour
- Full-time
- Hybrid work
- 5 years
- Writing skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
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Safety Operations Program Specialist
Washington Metrorail Safety Commission —Washington, DC
- Overnight shift
- Hybrid work
- Data analysis skills
- 3 years
- Driver's License
- Health insurance
- Dental insurance
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Specialist, Corporate Governance
Financial Industry Regulatory Authority, Inc. —Washington, DC
- $72,400 - $155,100 a year
- Extended hours
- Hybrid work
- Microsoft Excel
- Mid-level
- Office
- Paid jury duty
- Commuter assistance
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Security Analyst
Echo Five Group —Washington Navy Yard, DC
- $95,000 - $105,000 a year
- Full-time
- Background check
- Microsoft Excel
- Research
- Health insurance
- 401(k)
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Peer Support Specialist
The Montgomery County Coalition for the Homeless —Rockville, MD
- $21.63 - $24.03 an hour
- Computer literacy
- Mid-level
- High school diploma or GED
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Program Support Specialist - Mid
Cherokee Federal —Washington, DC
- $82,000 - $89,000 a year
- Full-time
- 5 years
- Research
- Office
- AD&D insurance
- Disability insurance
Program Coordinator
Aya Healthcare —Washington, DC
- $72 - $75 an hour
- Full-time
- RN License
- Mid-level
- 3 years
- Health insurance
- Dental insurance
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3d
Hepatitis C Peer Specialist
Changing Technologies, Inc. —Washington, DC
- $27 an hour
- Weekends as needed
- Background check
- Pass drug screening
- High school diploma or GED
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DoW Cyber Apprenticeship Program
National Security Agency —Fort Meade, MD
- Entry level
- On-the-job training
9d
Administrative Support Specialist
P3S CORPORATION —Washington, DC
- $65,000 - $80,000 a year
- Full-time
- Remote
- Microsoft Outlook
- Customer service
- Mid-level
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10d
Program Support Specialist- Mid Level
A3 Technology, Inc. —Washington, DC
- $50,000 - $175,000 a year
- Full-time
- 5 years
- Research
- Mid-level
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12d
Customer Support Specialist
InfoTrack US —Washington, DC
- $40,160 - $60,000 a year
- Full-time
- Remote
- Fair chance
- Communication skills
- Entry level
- AD&D insurance
- Paid holidays
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Program Support Administrative Specialist (5509)
Three Saints Bay, LLC —Washington, DC
- Background check
- Research
- Mid-level
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Program Specialist, Advocacy & Justice Clinic
District of Columbia Bar —Washington, DC
- $60,000 - $65,000 a year
- Weekends as needed
- Hybrid work
- Microsoft Word
- Spanish
- Writing skills
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Documentation Specialist
ResolveSoft Inc —Washington, DC
- $45,000 - $65,000 a year
- Remote
- Microsoft Excel
- English
- Mid-level
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Administrative Program Specialist I, II & III
IBSS Corporation —Silver Spring, MD
- $55,000 - $120,000 a year
- Remote
- 5 years
- Mid-level
- Databases
- Paid holidays
- Health insurance
Quick Apply
1d
Correctional Program Specialist (Executive Assistant)
US Bureau of Prisons/Federal Prison System —Washington, DC
- $169,279 - $197,200 a year
- Online Application
- Writing skills
- Pass drug screening
- Office
4d
Program Specialist I
PEOPLE TECHNOLOGY AND PROCESSES LLC —Arlington, VA
- Full-time
- Mid-level
- Communication skills
Quick Apply
Operations Specialist I, Aerospace & Defense (US)
Airspace —Washington, DC
- $20 - $22 an hour
- Remote
- Communication skills
- Entry level
- Dental insurance
- 401(k)
Quick Apply
Help Desk Specialist
Ardent Eagle Solutions —Washington, DC
- $26 - $33 an hour
- Full-time
- Hybrid work
- Computer Science
- Mid-level
- Office
- Paid time off
- Work from home

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FDA Submissions Specialist

Confidential Healthcare Company
Silver Spring, MD

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

Program Specialist Job jobs in Washington, DC

FDA Submissions Specialist

Safety Operations Program Specialist

Specialist, Corporate Governance

Security Analyst

Peer Support Specialist

Program Support Specialist - Mid

Program Coordinator

Hepatitis C Peer Specialist

DoW Cyber Apprenticeship Program

Administrative Support Specialist

Program Support Specialist- Mid Level

Customer Support Specialist

Program Support Administrative Specialist (5509)

Program Specialist, Advocacy & Justice Clinic

Documentation Specialist

Administrative Program Specialist I, II & III

Correctional Program Specialist (Executive Assistant)

Program Specialist I

Operations Specialist I, Aerospace & Defense (US)

Help Desk Specialist

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