Top 6584 senior partner Jobs in carson 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 Controller (IPO Readiness-Bilingual in Korean)
Confidential —Fullerton, CA
- $180,000 - $200,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Oracle
- Disability insurance
- Health insurance
Quick Apply
Director of Quality
INTERCONNECT SOLUTIONS COMPANY LLC —Fountain Valley, CA
- $120,000 - $140,000 a year
- Full-time
- 5 years
- Engineering
- Organizational skills
Quick Apply
Assistant Vice President, Asset Management
Griffin Capital Company —El Segundo, CA
- $135,000 - $165,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- 6 years
- Research
- Paid holidays
- Disability insurance
Senior Manager, Planning
Stellant Systems —Torrance, CA
- $150,000 - $170,000 a year
- Full-time
- Oracle
- 5 years
- Analysis skills
Sales Representative for Medical Device and Products
Dr U Hair and Skin Clinic —Manhattan Beach, CA
- $25 - $28 an hour
- 8 hour shift
- Hybrid work
- Up to 50% travel
- Sales
- Salesforce
- Paid training
- Health insurance
Quick Apply
ICMS Case Manager
LINC HOUSING CORPORATION —Wilmington, CA
- $23.69 - $27.87 an hour
- Weekends as needed
- Microsoft Word
- Background check
- Writing skills
- Disability insurance
- Health insurance
Quick Apply
Creative Manager
Lazy Acres Natural Market —Carson, CA
- $95,000 - $115,000 a year
- Full-time
- Background check
- Marketing
- Basic math
- Health savings account
- Health insurance
Quick Apply
5d
Program Manager, Ambulatory Patient Experience
Torrance Memorial Physician Network —Torrance, CA
- $38 - $61 an hour
- Full-time
- Oracle
- Clinic
- Presentation skills
- Health insurance
- Dental insurance
Quick Apply
Area Sales Manager, Carson
PepsiCo —Carson, CA
- $110,700 - $185,250 a year
- Weekends as needed
- 5 years
- Merchandising
- Bachelor's degree
- Paid parental leave
- Health insurance
12d
Executive Operations Partner, Office of the CEO (OCEO)
Heart Aerospace —Torrance, CA
- $98,000 - $120,000 a year
- 5 years
- Office
- Conflict management
Executive Administrative Partner, Office of the Chief People Officer
The Aerospace Corporation —El Segundo, CA
- $45.68 - $68.52 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Customer service
- Paid holidays
- Relocation assistance
Workday HCM Analyst
See's Candies —Carson, CA
- $125,000 a year
- Full-time
- Computer science
- Computer Science
- 5 years
Director of Operations and Business Development
Cornerstone Caregiving —Torrance, CA
- $80,000 a year
- Full-time
- Office
- Home Health
- In-person
- Health insurance
- Dental insurance
8d
Senior Executive Assistant
Relativity Space —Long Beach, CA
- $107,000 - $147,500 a year
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Opportunities for advancement
Quick Apply
Senior Catering Sales Manager - Porsche
Bon Appetit —Carson, CA
- $85,000 - $95,000 a year
- Full-time
- Background check
- Microsoft Excel
- Marketing
- Commuter assistance
- Paid parental leave
Quick Apply
Council Aide (Full-Time)
City of Carson —Carson, CA
- $37.92 - $48.39 an hour
- Weekends as needed
- Background check
- Mid-level
- Office
Executive Administrative Partner, Office of the Executive Vice President
The Aerospace Corporation —El Segundo, CA
- $50.40 - $75.60 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Office
- Paid holidays
- Relocation assistance
6d
Administrative Manager
LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA —Torrance, CA
- $80,000 - $130,000 a year
- University
- Bachelor's degree
- Children
Quick Apply
13d
Sr HR Generalist
Honeywell Aerospace —Torrance, CA
- Full-time
- Hybrid work
- Office
- Recruiting
- Senior level
5d

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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 partner jobs in carson ca

FDA Submissions Specialist

Senior Controller (IPO Readiness-Bilingual in Korean)

Director of Quality

Assistant Vice President, Asset Management

Senior Manager, Planning

Sales Representative for Medical Device and Products

ICMS Case Manager

Creative Manager

Program Manager, Ambulatory Patient Experience

Area Sales Manager, Carson

Executive Operations Partner, Office of the CEO (OCEO)

Executive Administrative Partner, Office of the Chief People Officer

Workday HCM Analyst

Director of Operations and Business Development

Senior Executive Assistant

Senior Catering Sales Manager - Porsche

Council Aide (Full-Time)

Executive Administrative Partner, Office of the Executive Vice President

Administrative Manager

Sr HR Generalist

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