Top 4299 Cmc Jobs | SimplyHired

FDA Submissions Specialist
Confidential Healthcare Company —Los Angeles, CA
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- Doctor of Philosophy
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MT. GRAHAM REGIONAL MEDICAL CENTER INC. —Safford, AZ
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Cabot Coach Builders —Haverhill, MA
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CMC Carrier —San Francisco, CA
- $75,000 - $90,000 a year
- Full-time
- OSHA
- Construction site
- 5 years
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Maintenance Mechanic
sg360° —Wheeling, IL
- Full-time
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Outpatient Physical Therapist
Covenant Health —Crossville, TN
- Full-time
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Project Engineer - Great Lakes
Commercial Metals Company —North Carolina
- Microsoft Excel
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Hospitalist Nurse Practitioner or Physician Assistant
Community Health Systems —Carlsbad, NM
- Full-time
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Pharmacy Technician
VytlOne —Conway, SC
- $21 - $27 an hour
- Full-time
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Commercial Tire Technician
CMC Tire Inc. —Sparks, NV
- $22 - $26 an hour
- Full-time
- Mid-level
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RN - PCU
TalentBurst, Inc. —Shelby, NC
- Rotating weekends
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Medical Field Case Manager
Enlyte —Augusta, GA
- $80,000 - $90,000 a year
- Full-time
- Hybrid work
- Nursing
- Microsoft Outlook
- RN License
- Travel reimbursement
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Chief Medical Officer (CMO)
St. Charles Campus, Good Samaritan University Hospital —Port Jefferson, NY
- $385,000 - $550,000 a year
- Full-time
- Medicine
- BC/BE
- US work authorization
- Health savings account
- Health insurance
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Special Education Case Manager
Somerset Academy Collegiate —San Antonio, TX
- $65,000 - $75,500 a year
- Overtime
- Background check
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- 5 years
- Health insurance
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DIRECTOR OF GALA & SPECIAL EVENTS FUNDRAISING
Vellore Christian Medical College Foundation —New York, NY
- $70,000 - $80,000 a year
- Full-time
- Hybrid work
- Business development experience
- Bachelor's degree
- US work authorization
- Health insurance
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Infection Preventionist, Post-Acute Services
Community Health System —Fresno, CA
- $55.48 - $70.60 an hour
- 8 hour shift
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Medical Field Case Manager
Enlyte —Marietta, GA
- $80,000 - $83,000 a year
- Full-time
- Hybrid work
- Nursing
- Microsoft Outlook
- RN License
- Travel reimbursement
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HVAC Service Technician -Baton Rouge
Calcasieu Mechanical Contractors —Baton Rouge, LA
- 8 hour shift
- Background check
- Clean driving record
- Schematics
- Paid holidays
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Registered Nurse (RN), Electrophysiology-$10,000 Sign On Bonus
Virginia Heart —Falls Church, VA
- $36.00 - $40.50 an hour
- Full-time
- Nursing
- Surgery
- RN License
- Disability insurance
- Health insurance
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Associate Director of Business Development - Northeast US (Biotech Services)
Coriolis Pharma Research GmbH —Boston, MA
- Up to 50% travel
- Customer service
- 5 years
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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

cmc jobs

FDA Submissions Specialist

Advance Practice Provider - CMC - NEW LOCATION IN THATCHER

Lead Vehicle Electrical Systems Technician – Custom Vehicle Integration (2+ Years Experience Require

Tile Installation Specialist Team Leader

Maintenance Mechanic

Outpatient Physical Therapist

Project Engineer - Great Lakes

Hospitalist Nurse Practitioner or Physician Assistant

Pharmacy Technician

Commercial Tire Technician

RN - PCU

Medical Field Case Manager

Chief Medical Officer (CMO)

Special Education Case Manager

DIRECTOR OF GALA & SPECIAL EVENTS FUNDRAISING

Infection Preventionist, Post-Acute Services

Medical Field Case Manager

HVAC Service Technician -Baton Rouge

Registered Nurse (RN), Electrophysiology-$10,000 Sign On Bonus

Associate Director of Business Development - Northeast US (Biotech Services)

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