Top 41 Regulatory affairs Jobs in Ontario Ca

Chief Regulatory Affairs Officer
Restem Group Inc. / thebiobox LLC —Corona, CA
- $200,000 - $225,000 a year
- Full-time
- Medicine
- Office
- Doctor of Philosophy
Quick Apply
Director of Regulatory Compliance
Feit Electric —Pico Rivera, CA
- $125,000 - $140,000 a year
- Email
- Background check
- Management
- Engineering
- Health insurance
- Dental insurance
Quick Apply
Entry-Level Compliance Assistan
Prime Wire and Cable Inc. —Diamond Bar, CA
- From $25 an hour
- Full-time
- Microsoft Excel
- Bachelor's degree
- Organizational skills
- Health insurance
- Dental insurance
Quick Apply
11d
Assistant Regulatory Affairs Coordinator - Hybrid
University of California, Irvine —Orange, CA
- $31.11 - $51.25 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Regulatory Affairs Specialist II
City of Hope —Duarte, CA
- $40.82 - $63.27 an hour
- Full-time
- Mid-level
- Master's degree
- Bachelor's degree
Regulatory Affairs Coordinator
University of California, Irvine —Orange, CA
- $37.56 - $61.91 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Regulatory Affairs Specialist II
Prolacta Bioscience —Duarte, CA
- $43.75 - $49.00 an hour
- Full-time
- Hybrid work
- Mid-level
- Residential
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
Senior Specialist Regulatory Affairs
Stryker —Irvine, CA
- $95,800 - $159,600 a year
- Full-time
- Engineering
- Mid-level
- Office
- Health savings account
- AD&D insurance
5d
Quality Assurance Coordinator - Hybrid
University of California, Irvine —Orange, CA
- $33.04 - $57.88 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Sr. Regulatory Affairs Specialist - Ad/Promo
Prolacta Bioscience —Duarte, CA
- $112,000 - $125,000 a year
- Full-time
- Hybrid work
- 6 years
- Residential
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
Compliance Associate
Wismettac Asian Foods, Inc. —Santa Fe Springs, CA
- $28.00 - $33.90 an hour
- Overtime
- Microsoft Excel
- Research
- Office
- Wellness program
- Health insurance
Quick Apply
Special Programs Manager I - Commercial Products
Inland Empire Health Plan —Rancho Cucamonga, CA
- $80,059.20 - $106,059.20 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Disability insurance
- Health insurance
Project Manager, Regulatory Affairs
JENAVALVE TECHNOLOGY INC —Irvine, CA
- $130,000 - $140,000 a year
- Full-time
- Remote
- 5 years
- Project management
- Travel
Quick Apply
13d
Quality Control Technician - Spread (Chino, CA)
In-N-Out —Chino, CA
- $28.37 - $31.38 an hour
- Overtime
- Microsoft Excel
- Bachelor of Science
- Mid-level
- Profit sharing
- Health insurance
Product Complaint Associate
STAAR Surgical —Monrovia, CA
- $25 - $32 an hour
- Writing skills
- Mid-level
- High school diploma or GED
Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert)
BIOTRONIK —Tustin, CA
- $165,000 - $185,000 a year
- Online Application
- Hybrid work
- 7 years
- Office
- Bachelor's degree
- Health savings account
- Health insurance
Federal Compliance Analyst, Principal
OCTA —Orange, CA
- $111,654.40 - $153,628.80 a year
- Full-time
- 5 years
- Research
- Office
R&D Lab Technical Specialist II
Ormco —Pomona, CA
- $27.70 - $33.90 an hour
- Mid-level
- Bachelor's degree
- 2 years
- Paid holidays
- Disability insurance
2d
Quality Control Technician - Meat (Chino, CA)
In-N-Out —Chino, CA
- $28.37 - $31.38 an hour
- 8 hour shift
- Microsoft Excel
- Bachelor of Science
- Mid-level
- Profit sharing
- Health insurance
Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert)
BIOTRONIK SE & Co. KG —Tustin, CA
- $165,000 - $185,000 a year
- Online Application
- Hybrid work
- 7 years
- Office
- Bachelor's degree
- Health insurance
- Paid time off

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Chief Regulatory Affairs Officer

Restem Group Inc. / thebiobox LLC
Corona, CA

Quick Apply

Job Details

Full-time
$200,000 - $225,000 a year

Qualifications

Biotechnology
Decision making
Senior leadership

Full Job Description

About Restem/BioBox LLC

Restem is a clinical-stage biotechnology company advancing next-generation cell therapies designed to modulate the immune system and treat inflammatory, autoimmune, and age-related diseases. With a passionate team dedicated to restoring health through innovation and a robust pipeline that includes proprietary cellular therapeutics such as Restem-L and activated natural killer (aNK) programs, we are transforming cutting-edge science into life-changing treatments. Restem is headquartered in Miami, FL, with labs and manufacturing facilities in Corona, CA. (Restem)

JOB TITLE: Chief Regulatory Affairs Officer (CRAO)
EMPLOYER: RESTEM Group, Inc.
REPORTS TO: Chief Executive Officer (CEO)
EXECUTIVE LEVEL: C-Suite

POSITION SUMMARY

The Chief Regulatory Affairs Officer (CRAO) will serve as a key member of RESTEM’s executive leadership team, responsible for defining and leading the Company’s global regulatory strategy across its innovative cell-based therapeutic platforms. This role is highly strategic in nature and is designed for a seasoned regulatory leader who brings deep experience, sound judgment, and executive presence to guide regulatory pathways from clinical development through commercialization.

The CRAO will act as the Company’s senior regulatory authority and primary strategic interface with global regulatory agencies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other international regulators. This leader will advise the CEO, Board of Directors, and executive team on regulatory risk, timelines, and opportunities, enabling efficient development, regulatory alignment, and long-term value creation. The Company is committed to empowering the CRAO with the autonomy, resources, and organizational flexibility required to build a world-class regulatory function.

RESTEM is seeking a regulatory leader who can architect regulatory strategy, anticipate regulatory expectations, and partner closely with internal teams to ensure alignment, while being supported by experienced operational, quality, and clinical teams.

KEY RESPONSIBILITIES

Regulatory Strategy and Executive Leadership

Define and own RESTEM’s global regulatory strategy across clinical development, CMC, non-clinical programs, and commercialization.
Provide executive oversight of regulatory planning across product lifecycles, from early development through registration and post-approval activities.
Advise executive leadership and the Board on regulatory risk, regulatory science considerations, and strategic decision-making.
Shape regulatory pathways for innovative cell-based and biologic therapies addressing high unmet medical needs.

FDA and Global Regulatory Engagement

Serve as the Company’s primary strategic liaison with the FDA, EMA, and other global regulatory authorities.
Lead and participate in key regulatory interactions, including Pre-IND, IND, End-of-Phase, Type A, B, and C meetings, advisory committee engagements, and pre-BLA or pre-NDA discussions.
Provide strategic oversight for regulatory submissions, including INDs, CTAs, BLAs, NDAs, and lifecycle management activities, in collaboration with internal and external teams.
Anticipate regulatory expectations and guide internal planning to support efficient and predictable development timelines.

Cross-Functional Partnership

Partner closely with Clinical, R&D, Manufacturing, Quality, Legal, and Commercial leadership to integrate regulatory considerations into development and business plans.
Provide executive regulatory guidance related to labeling, promotional strategy, and post-market commitments.
Support regulatory due diligence for partnerships, licensing opportunities, and strategic transactions.

Oversight of Regulatory and Quality Infrastructure

Provide executive oversight and strategic alignment of regulatory affairs, quality systems, and compliance functions, in partnership with operational leadership.
Ensure inspection readiness through strategic governance, rather than day-to-day operational management.
Guide responses to regulatory inspections, observations, and correspondence at an executive level.

Leadership and Organizational Development

Build and mentor a high-performing Regulatory Affairs organization as the Company grows.
Evaluate and evolve the Regulatory Affairs function over time, including the ability to recommend hires and to develop, and scale internal teams and external advisors to support the Company’s evolving pipeline and growth.
Establish scalable regulatory processes, governance frameworks, and external advisory support as needed.
Engage and oversee external regulatory consultants and advisors to support execution.

SCOPE AND AUTHORITY

Executive-level role with direct access to the CEO and Board of Directors.
Owns global regulatory strategy and regulatory decision frameworks.
Represents RESTEM externally with regulators, partners, and key stakeholders.
Signals seniority, credibility, and decision authority to regulators and investors.
Focused on cell-based and biologic therapeutic platforms.

SKILLS AND QUALIFICATIONS

Advanced degree required (PhD, PharmD, MD, JD, or MS) in Life Sciences, Regulatory Affairs, Pharmacy, Medicine, or a related field. Deep, hands-on knowledge of FDA regulatory frameworks, CBER processes, and biologics development.
Strong understanding of global regulatory systems, including EMA and other international authorities.
Experience guiding clinical development programs through complex regulatory environments.
Broad familiarity with cGMP, cGCP, cGLP, and quality systems at a strategic oversight level.
Exceptional regulatory judgment, executive presence, and communication skills.
Ability to influence cross-functional teams and senior stakeholders.
High ethical standards and commitment to patient safety and regulatory integrity.
Strategic mindset with the ability to translate regulatory science into practical business decisions.

ROLE EXPECTATION STATEMENT

This role is designed to focus on regulatory strategy, leadership, and decision-making, with the execution to be supported by experienced internal teams and external partners. The CRAO will define direction, guide teams, and provide executive oversight, while being supported by experienced clinical, quality, and operational functions. RESTEM values regulatory excellence, sound judgment, and partnership, and is committed to providing the resources and organizational support required for success in this role.

If you meet the qualifications and are interested, we look forward to you applying online.

We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other legally protected status. All employment decisions are based on business needs, job requirements, and individual qualifications, in accordance with applicable federal, state, and local laws.

Job Type: Full-time

Pay: $200,000.00 - $225,000.00 per year

Application Question(s):

What is your desired salary range?
Which degree(s) have you obtained and in which field(s)?

Work Location: In person

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Refine Your Search

regulatory affairs jobs in ontario ca

Chief Regulatory Affairs Officer

Director of Regulatory Compliance

Entry-Level Compliance Assistan

Assistant Regulatory Affairs Coordinator - Hybrid

Regulatory Affairs Specialist II

Regulatory Affairs Coordinator

Regulatory Affairs Specialist II

Senior Specialist Regulatory Affairs

Quality Assurance Coordinator - Hybrid

Sr. Regulatory Affairs Specialist - Ad/Promo

Compliance Associate

Special Programs Manager I - Commercial Products

Project Manager, Regulatory Affairs

Quality Control Technician - Spread (Chino, CA)

Product Complaint Associate

Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert)

Federal Compliance Analyst, Principal

R&D Lab Technical Specialist II

Quality Control Technician - Meat (Chino, CA)

Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert)

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