Top 210406 Program Specialist 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
Community Resource Specialist | PACE Program
MIDLAND CARE CONNECTION INC —Lawrence, KS
- Full-time
- Bilingual
- High school diploma or GED
- Driver's License
- Continuing education credits
- 403(b) matching
Quick Apply
5d
HR Specialist
Sunburst Chemicals, Inc. —Minneapolis, MN
- $60,000 - $67,000 a year
- Full-time
- Data analysis skills
- Mid-level
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
Senior Labor and Employee Relations Specialist
JCDecaux North America —New York, NY
- $90,000 - $100,000 a year
- Full-time
- Spanish
- English
- Master's degree
- Wellness program
- Commuter assistance
Quick Apply
9d
Sr.Project Specialist-Warehouse Operation
SHEIN —Cherry Valley, CA
- $90,000 - $105,000 a year
- Full-time
- Mid-level
- Continuous improvement
- Warehouse
- Health insurance
- Dental insurance
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Program Support Specialist
Sol Firm —Remote
- $80,000 - $90,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- PMP
- Health insurance
- Dental insurance
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5d
Remote - Security Program Management Specialist
Parsons —Remote
- $88,400 - $154,700 a year
- Remote
- Bachelor's degree
- SharePoint
- Senior level
- Wellness program
- Paid holidays
Case Research & Coordination Specialist - Human Services Program - Remote
The Workforce Group —Remote
- Remote
- Background check
- Spanish
- Pass drug screening
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Affordable Housing Compliance Specialist II - Remote
RealPage, Inc. —Richardson, TX
- $50,500 - $85,900 a year
- Mid-level
- 2 years
- Communication skills
- Paid holidays
- Dental insurance
Contract Specialist II (Federal Acquisition)
Stafford Consulting —Remote
- $70,000 - $85,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Contracts
- Health insurance
- Dental insurance
Quick Apply
6d
Training Specialist
Software Technology Inc —Nashville, TN
- Research
- Mid-level
- Communication skills
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Program Specialist CCPP - Long Beach
Children's Home Society of California —Long Beach, CA
- $24.96 - $29.21 an hour
- Weekends as needed
- Hybrid work
- Spanish
- Microsoft Excel
- Microsoft Outlook
- Paid holidays
- Health insurance
Quick Apply
Training Specialist
Software Technology Inc —Nashville, TN
- 8 hour shift
- Research
- Mid-level
- In-person
- Flexible schedule
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CalWORKs Program Specialist
UC Davis —California
- $98,000 - $108,000 a year
- Writing skills
- Bachelor's degree
- Continuous improvement
- Paid holidays
- Health insurance
3d
Program Specialist
California State University —Fresno, CA
- Email
- Background check
- Customer service
- Writing skills
- Paid holidays
- Health insurance
Research Specialist II
Measurement Incorporated —Remote
- $74,000 - $84,000 a year
- Email
- Remote
- Master's degree
- Bachelor's degree
- Continuous improvement
Quick Apply
2d
Academic Program Specialist
Keck Medical Center of USC —Los Angeles, CA
- $29.76 - $30.90 an hour
- Full-time
- Background check
- Customer service
- Mid-level
Implementation Specialist
Hendall Inc —Rockville, MD
- $70,000 - $95,000 a year
- Full-time
- Remote
- Microsoft Excel
- 5 years
- Public speaking
Quick Apply
Integration Specialist
BEST FRIENDS PET CARE INC —Irvine, CA
- $60,000 - $70,000 a year
- Full-time
- Remote
- Mid-level
- Continuous improvement
- Travel
Quick Apply
Program Specialist (Oncology)
Johns Hopkins University —Baltimore, MD
- $53,800 - $94,400 a year
- Full-time
- Hybrid work
- Background check
- Mid-level
- Office

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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

Program Specialist jobs

FDA Submissions Specialist

Community Resource Specialist | PACE Program

HR Specialist

Senior Labor and Employee Relations Specialist

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Program Support Specialist

Remote - Security Program Management Specialist

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Contract Specialist II (Federal Acquisition)

Training Specialist

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Training Specialist

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Research Specialist II

Academic Program Specialist

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Program Specialist (Oncology)

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