Top 7651 senior program Jobs in los angeles, 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
Senior Executive Assistant (Bilingual English- Korean required)
SIC Enterprise Inc —Fullerton, CA
- $90,000 - $110,000 a year
- Full-time
- Microsoft Excel
- Customer service
- No background check
- Health insurance
- Dental insurance
Quick Apply
Director of Development
Westmark School —Encino, CA
- $115,000 - $145,000 a year
- Full-time
- Background check
- School experience
- 7 years
- 403(b) matching
- Health insurance
Quick Apply
Director of Compliance
Griffin Capital Company —El Segundo, CA
- $135,000 - $165,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Office
- Finance
- Paid holidays
- Disability insurance
7d
Decision Support Analyst
A² Systems Engineering —El Segundo, CA
- $150,000 - $180,000 a year
- Computer Science
- Research
- Analysis skills
- Paid jury duty
- AD&D insurance
Program Coordinator
1736 FAMILY CRISIS CENTER —Los Angeles, CA
- $67,000 - $75,000 a year
- Background check
- HIPAA
- Mid-level
Quick Apply
Data Systems Manager
United Friends of the Children —Los Angeles, CA
- $70,304 - $82,000 a year
- Weekends as needed
- Hybrid work
- Microsoft Excel
- Microsoft Access
- System design
- Health insurance
- Dental insurance
Quick Apply
Assistant Property Manager
Cushman & Wakefield —Los Angeles, CA
- $33.55 - $39.47 an hour
- Full-time
- Mid-level
- Office
- High school diploma or GED
- Health savings account
- Disability insurance
Quick Apply
Administrative Assistant
Apple —Culver City, CA
- $38.32 - $67.01 an hour
- Mid-level
- Office
- Bachelor's degree
- Employee stock purchase plan
- Health insurance
Executive Assistant
Children's Hospital Los Angeles —Los Angeles, CA
- $61,152 - $100,464 a year
- 8 hour shift
- Surgery
- Microsoft Office
- Bachelor's degree
Senior Creative Project Manager
Mindbody —Los Angeles, CA
- $86,475 - $115,300 a year
- Remote
- Mid-level
- 4 years
Quick Apply
6d
Executive Assistant
QueensCare —Los Angeles, CA
- $84,088 - $105,086 a year
- Weekends as needed
- Research
- Office
- High school diploma or GED
Quick Apply
Temporary Branch Security Officer - Century City
Tiffany & Co. —Los Angeles, CA
- $22.53 - $30.48 an hour
- Temporary
- Sales
- Computer literacy
- High school diploma or GED
Director, Community Engagement
sweetgreen —Los Angeles, CA
- $135,000 - $191,000 a year
- Hybrid work
- Management
- Office
- 8 years
- Health savings account
- Health insurance
Communications Assistant
The Buckley School —Los Angeles, CA
- $25 - $28 an hour
- Full-time
- Bachelor's degree
- Children
- Experience equivalent to degree accepted
- AD&D insurance
- Health insurance
Quick Apply
9d
Lower School Librarian
The Buckley School —Los Angeles, CA
- $65,041 - $134,160 a year
- Part-time
- School experience
- Computer literacy
- Writing skills
- AD&D insurance
- Health insurance
Quick Apply
Engagement and Organizing Advisor
Oxfam America —Los Angeles, CA
- $75,000 - $80,000 a year
- Full-time
- Remote
- Spanish
- Writing skills
- Mid-level
Quick Apply
Executive Assistant
Live Nation —Beverly Hills, CA
- $130,000 - $150,000 a year
- Weekends as needed
- 5 years
- Mid-level
- Office
- Flexible schedule
Senior Researcher, B2B
Live Nation —Los Angeles, CA
- $108,000 - $135,000 a year
- Full-time
- Remote
- 5 years
- Analysis skills
- Presentation skills
- Health savings account
- Paid holidays
6d
Branch Security Officer - Beverly Hills, Rodeo Dr.
Tiffany & Co. —Los Angeles, CA
- $22.53 - $30.48 an hour
- Weekends as needed
- Sales
- Computer literacy
- High school diploma or GED

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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

senior program jobs in los angeles, ca

FDA Submissions Specialist

Senior Executive Assistant (Bilingual English- Korean required)

Director of Development

Director of Compliance

Decision Support Analyst

Program Coordinator

Data Systems Manager

Assistant Property Manager

Administrative Assistant

Executive Assistant

Senior Creative Project Manager

Executive Assistant

Temporary Branch Security Officer - Century City

Director, Community Engagement

Communications Assistant

Lower School Librarian

Engagement and Organizing Advisor

Executive Assistant

Senior Researcher, B2B

Branch Security Officer - Beverly Hills, Rodeo Dr.

I want to receive the latest job alert for senior program in los angeles, ca

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