Top 127901 Program Specialist Training 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
Psychiatric Rehabilitation Specialist
Interborough Developmental and Consultation Center —Brooklyn, NY
- $70,000 - $75,000 a year
- Weekends as needed
- Bilingual
- Background check
- Spanish
- Profit sharing
- Health insurance
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Critical Intervention Specialist
CBEM LLC —Sacramento, CA
- $72,510.98 a year
- Full-time
- Experience working with individuals with developmental disabilities
- Mid-level
- Driver's License
- Travel reimbursement
- Paid holidays
Semiconductor / Chemical Safety Engineer / Specialist
Microcircuit Emulation Center at SRI International —Princeton, NJ
- $79,533 - $105,381 a year
- Full-time
- Mid-level
- In-person
- 2 years
- Health savings account
- Relocation assistance
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Process Documentation/Training Specialist
Kelly Services —Hillsboro, OR
- $38 an hour
- Full-time
- Hybrid work
- Mid-level
- Continuous improvement
- US work authorization
- Paid holidays
- Disability insurance
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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
Utilities Right of Way Document Specialist - Remote
ORC —Remote
- $25 - $35 an hour
- Online Application
- Background check
- Customer service
- English
- Travel reimbursement
- Paid holidays
Quick Apply
Monitoring and Evaluation Specialist, CDC
Dexis Consulting Group —Washington, DC
- Mid-level
- Master's degree
- Analysis skills
- Health insurance
Senior Training Specialist - Hybrid
EmblemHealth —New York, NY
- $56,160 - $99,360 a year
- Full-time
- Background check
- Classroom
- Microsoft Outlook
- Health insurance
- Dental insurance
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Training Specialist I
Seneca Gaming Corporation —Niagara Falls, NY
- From $22 an hour
- Full-time
- 18 years or older
- Mid-level
- High school diploma or GED
Critical Intervention Specialist
CBEM LLC —San Francisco, CA
- $78,554.36 a year
- Full-time
- Experience working with individuals with developmental disabilities
- Mid-level
- Driver's License
- Travel reimbursement
- Paid holidays
Quick Apply
Subrogation Specialist
SAFETY INSURANCE COMPANY —Boston, MA
- $60,000 - $80,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- 3 years
- Paid holidays
- Health insurance
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NEPA Program Specialist
Whitetail Environmental, LLC —Mountain View, CA
- $100,000 - $125,000 a year
- Full-time
- Hybrid work
- Research
- 8 years
- Driver's License
- Health insurance
- Dental insurance
Quick Apply
5d
Veracross Student Information System Data Specialist
International School of Boston —Cambridge, MA
- $70,000 - $100,000 a year
- Full-time
- School experience
- English
- Mid-level
- Health savings account
- Health insurance
Quick Apply
11d
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
Patient Experience and Customer Service Training Specialist
HRC Fertility Management —Pasadena, CA
- $65,000 - $75,000 a year
- Full-time
- Public speaking
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
6d
Progam Evaluation Associate
SBS Evaluation & Program Development Specialists —Albuquerque, NM
- $25 - $40 an hour
- Part-time
- Hybrid work
- Addiction Medicine
- Mid-level
- Master's degree
Quick Apply
ERP Specialist
SCHROTH Safety Products LLC —Fort Lauderdale, FL
- From $60,000 a year
- Full-time
- Background check
- ERP systems
- English
- Health savings account
- Health insurance
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

Program Specialist Training jobs

FDA Submissions Specialist

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

Psychiatric Rehabilitation Specialist

Critical Intervention Specialist

Semiconductor / Chemical Safety Engineer / Specialist

Process Documentation/Training Specialist

Case Research & Coordination Specialist - Human Services Program - Remote

Affordable Housing Compliance Specialist II - Remote

Utilities Right of Way Document Specialist - Remote

Monitoring and Evaluation Specialist, CDC

Senior Training Specialist - Hybrid

Training Specialist I

Critical Intervention Specialist

Subrogation Specialist

NEPA Program Specialist

Veracross Student Information System Data Specialist

HR Specialist

Patient Experience and Customer Service Training Specialist

Progam Evaluation Associate

ERP Specialist

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