Top 3139 Support specialist Jobs in Pasadena Ca

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
HVACR Technical Support Specialist – Refrigeration (Walk-In Coolers/Freezers)
Turbo Air —Long Beach, CA
- $60,000 - $70,000 a year
- Full-time
- 5 years
- Office
- In-person
- Health insurance
- Dental insurance
Quick Apply
Licensed Professional Counselor
Headway —California
- Up to $117.73 an hour
- Remote
- Private practice
- Master's degree
- Senior level
Licensed Professional Clinical Counselor
Grow Therapy —California
- $70 - $98 an hour
- Part-time
- Remote
- Mid-level
- In-person
- Continuing education credits
- Professional development assistance
Financial Care Specialist
HRC Fertility Management —Encino, CA
- $23 - $25 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Writing skills
Quick Apply
8d
Legal Administrative Specialist - Litigation
Morgan Lewis —Los Angeles, CA
- $86,825 - $113,131 a year
- Overtime
- Hybrid work
- 7 years
- Microsoft Excel
- Microsoft Outlook
PR & Communications Specialist
Gigabyte —City of Industry, CA
- $26 - $30 an hour
- Email
- Marketing
- Bachelor of Science
- English
- Paid holidays
- Health insurance
Quick Apply
Developmental Infant Stim Specialist (Birth-3)
Developmental Inc. —Los Angeles, CA
- $24 - $25 an hour
- Part-time
- Bilingual
- Driver's License
- Driving
- Travel reimbursement
- Tuition reimbursement
Quick Apply
Customer Support Specialist – Bathroom Products / Plumbing
Fullest LLC —Norwalk, CA
- $24 - $26 an hour
- Full-time
- Spanish
- Microsoft Excel
- Computer literacy
- Health insurance
- Dental insurance
Quick Apply
Portfolio Management Support Specialist
MidFirst Bank —Los Angeles, CA
- $35 - $46 an hour
- Customer service
- Mid-level
- Office
- Paid holidays
- Health insurance
Behavior Specialist - Hiring Now
Zen Educate —Glendale, CA
- $20 - $23 an hour
- Part-time
- Classroom
- 18 years or older
- CPR Certification
- Paid sick time
7d
Legal Intake Specialist
HBK Lawyers —Encino, CA
- $21 - $35 an hour
- Full-time
- Spanish
- Microsoft Outlook
- English
- Free parking
- Health insurance
Quick Apply
Early Intervention Specialist / ABA Therapist / RBT
Autism Spectrum Support Center —Los Angeles, CA
- $25 - $38 an hour
- 8 hour shift
- Background check
- Working with individuals with developmental disabilities
- Spanish
- Paid training
- Mileage reimbursement
Quick Apply
Education Specialist
MEXICAN AMERICAN OPPORTUNITY FOUNDATION —Montebello, CA
- $26.99 - $27.12 an hour
- Full-time
- Spanish
- Computer literacy
- Writing skills
- Paid jury duty
- 403(b) matching
Internal Control Specialist
RBD California Restaurants Limited dba KFC —City of Industry, CA
- $85,000 - $100,000 a year
- Weekends as needed
- Writing skills
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Business Development Specialist - Bilingual Chinese
Forest Lawn —Glendale, CA
- $31 - $37 an hour
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Writing skills
Behavior Specialist
Intensive Behavior Intervention Consultants, LLC —Los Angeles, CA
- $20 - $24 an hour
- Full-time
- Data analysis skills
- Psychology
- Computer skills
- Health insurance
- Dental insurance
Quick Apply
Quality Assurance Specialist I/II (20752441)
Tri-City Mental Health Authority —Los Angeles, CA
- $79,255.55 - $111,653.44 a year
- Email
- LMFT
- Psychiatry
- RN License
- AD&D insurance
- Paid holidays
7d
International Franchise seeks Print Production Specialist
Minuteman Press International —San Fernando Valley, CA
- $55,000 - $60,000 a year
- Full-time
- Sales
- Customer service
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
11d
Early Education Specialist
TEACH Together llc —Los Angeles, CA
- $29 - $35 an hour
- Temporary
- Bilingual
- School experience
- Classroom
Quick Apply
4d

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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.
Hybrid role but MUST be based out of Los Angeles, CA.

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

support specialist jobs in pasadena ca

FDA Submissions Specialist

HVACR Technical Support Specialist – Refrigeration (Walk-In Coolers/Freezers)

Licensed Professional Counselor

Licensed Professional Clinical Counselor

Financial Care Specialist

Legal Administrative Specialist - Litigation

PR & Communications Specialist

Developmental Infant Stim Specialist (Birth-3)

Customer Support Specialist – Bathroom Products / Plumbing

Portfolio Management Support Specialist

Behavior Specialist - Hiring Now

Legal Intake Specialist

Early Intervention Specialist / ABA Therapist / RBT

Education Specialist

Internal Control Specialist

Business Development Specialist - Bilingual Chinese

Behavior Specialist

Quality Assurance Specialist I/II (20752441)

International Franchise seeks Print Production Specialist

Early Education Specialist

I want to receive the latest job alert for support specialist in pasadena ca

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