Top 30 Regulatory affairs Jobs in Oceanside Ca

Project Manager / Senior Project Manager – Nonclinical Antiviral Development (NIAID Funded Program)
Arisan Therapeutics, Inc —Carlsbad, CA
- $145,000 - $189,000 a year
- Full-time
- Background check
- 5 years
- US work authorization
- Paid holidays
- Relocation assistance
Quick Apply
Consultant, Global Regulatory Affairs
Cullgen —San Diego, CA
- $300 an hour
- Hybrid work
- 11+ years
- Office
- Doctor of Philosophy
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Clinical Data Specialist II
Alphatec Spine —Carlsbad, CA
- $85,000 - $98,000 a year
- Full-time
- Mid-level
- SQL
- Analysis skills
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Senior Director, Regulatory Affairs-CA
Synchron Inc. —San Diego, CA
- $210,000 - $240,000 a year
- Engineering
- 11+ years
- Office
- Commuter assistance
- Disability insurance
Quick Apply
Associate Director, Regulatory and Medical Writer
Ionis Pharmaceuticals, Inc. —Carlsbad, CA
- $142,588 - $201,472 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Mentoring
Quick Apply
Director, Program Management
Vividion Therapeutics, Inc —San Diego, CA
- $210,000 - $235,000 a year
- 5 years
- Bachelor of Science
- Bachelor's degree
- Disability insurance
- Health insurance
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Senior Project Manager - Associate Director, CMC
CALIDI BIOTHERAPEUTICS INC —San Diego, CA
- $125,000 - $165,000 a year
- Full-time
- Bachelor of Science
- Basic math
- Laboratory experience
- Health insurance
- Dental insurance
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Senior Specialist, Product Performance, Medical Affairs
Abbott Laboratories —Temecula, CA
- $99,300 - $198,700 a year
- Full-time
- Nursing
- Medicine
- 5 years
- Health insurance
- Tuition reimbursement
Quality Control Analyst
Gallant —San Diego, CA
- From $70,000 a year
- Weekends as needed
- Background check
- Mid-level
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
Clinical Scientist II
Alphatec Spine —Carlsbad, CA
- $125,000 - $140,000 a year
- Full-time
- Mid-level
- Doctor of Philosophy
- US work authorization
Quick Apply
Senior Manager, Drug Safety
BLOSSOMHILL THERAPEUTICS INC —San Diego, CA
- $165,067 - $204,228 a year
- Full-time
- Nursing
- 6 years
- Office
Quick Apply
3d
Senior Manager, Pharmacovigilance
ORIC Pharmaceuticals —San Diego, CA
- $150,000 - $180,000 a year
- Full-time
- Nursing
- 5 years
- Writing skills
Quick Apply
Clinical Scientist
Fate Therapeutics —San Diego, CA
- $130,000 - $150,000 a year
- Full-time
- Office
- 3 years
- Presentation skills
Director / Senior Director of Regulatory Operations
Artiva Biotherapeutics —San Diego, CA
- $205,000 - $268,000 a year
- Full-time
- 11+ years
- Bachelor's degree
- Quality control
- Paid holidays
- Disability insurance
Quick Apply
Director of Permitting
SOLV Energy, LLC —San Diego, CA
- $150,080 - $187,600 a year
- Full-time
- 7 years
- Engineering
- Travel
- Paid holidays
- Disability insurance
Quick Apply
Vice President, Clinical Solutions Product Development
Illumina —San Diego, CA
- $295,400 - $443,200 a year
- Full-time
- Background check
- 11+ years
- Bachelor's degree
- Dental insurance
- Paid time off
Supervisor, Quality Control Biology
Artiva Biotherapeutics —San Diego, CA
- $110,000 - $135,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Management
- Paid holidays
- Disability insurance
Quick Apply
Senior Packaging and Product Compliance Specialist
Sony Electronics Inc —San Diego, CA
- $84,014 - $112,017 a year
- Full-time
- Microsoft Outlook
- 5 years
- Project management
- Paid parental leave
- Health insurance
Regulatory Manager- IVD and 510(k)
CorDx —San Diego, CA
- $90,000 - $150,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Senior level
- 401(k)
- Paid time off
Quick Apply
Associate Director, Medical Writing
Acadia Pharmaceuticals Inc. —San Diego, CA
- $157,000 - $196,500 a year
- 5 years
- Word processing
- Windows
- Paid parental leave
- Employee stock purchase plan
8d

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Project Manager / Senior Project Manager – Nonclinical Antiviral Development (NIAID Funded Program)

Arisan Therapeutics, Inc
Carlsbad, CA

Quick Apply

Job Details

Full-time
$145,000 - $189,000 a year

Benefits

Stock options
Paid holidays
Relocation assistance
Health insurance
401(k)
Paid time off
401(k) matching

Qualifications

Teamwork
Managing healthcare project budgets
DoD experience
Contract management experience in healthcare
Schedule management
Product development projects
Pharmaceutical company experience
Virology
Organizational skills
Chemistry, manufacturing & controls
Managing projects
Toxicology
Project contract management
Pharmaceutical research experience
Project stakeholder communication
Cross-functional communication
Stakeholder management

Full Job Description

Project Manager / Senior Project Manager – Nonclinical Antiviral Development (NIAID‑Funded Program)

We are a small, science‑driven biopharmaceutical company located in Carlsbad, CA, advancing first‑in‑class preclinical and Phase 2 clinical development programs primarily through U.S. government‑funded support. We operate with the agility of a startup and the rigor required for global regulatory success. Every team member plays a direct role in shaping the program and accelerating delivery of urgently needed antiviral therapies.

Position Summary

We are seeking an experienced, highly organized full-time, on-site Project Manager to lead a nonclinical antiviral development program from post-discovery through Phase 1. This individual will serve as the operational hub for a cross-functional team spanning nonclinical, CMC, regulatory, and external partners. The ideal candidate brings hands-on experience managing government-funded drug development contracts—preferably with NIH/NIAID, BARDA, or the Department of Defense—and understands the unique reporting, compliance, and milestone-driven expectations of government agencies. Additional pluses would include experience with antiviral or infectious disease programs, including advanced animal efficacy models and coordinating NIAID DMID-funded testing or development networks, as well as familiarity with IND-enabling requirements and early clinical development

This role is perfect for someone who thrives in a small‑company environment, enjoys building structure where needed, and can drive execution across multiple technical workstreams.

Key Responsibilities

Program Leadership & Execution

· Lead day-to-day project management for a small‑molecule antiviral program from post-discovery through IND and Phase 1.

· Develop and maintain integrated project plans, timelines, budgets, and risk registers.

· Drive cross-functional alignment across nonclinical, CMC, regulatory, and external collaborators.

· Ensure timely execution of studies supporting IND‑enabling packages (toxicology, safety pharmacology, ADME, virology, formulation, and manufacturing).

· Operate within a government contract framework, ensuring compliance with government contractual requirements.

Government Contract Management

· Manage contract deliverables, reporting requirements, milestone documentation, and compliance obligations.

· Serve as primary operational liaison with NIAID DMID program staff and technical teams.

· Coordinate government-funded testing through NIAID/NIH networks (e.g., antiviral screening, animal models, PK/PD studies).

· Ensure alignment with FDA study compliance and expectations for documentation, transparency, and audit readiness.

Vendor & CRO Oversight

· Manage relationships with CROs, CDMOs, academic collaborators, and government testing facilities.

· Support study initiation, execution, and delivery of high-quality data packages.

· Track performance, budgets, and timelines; escalate risks proactively.

Regulatory & NDA Support

· Partner with Regulatory Affairs to support NDA planning, data QC, cross‑functional readiness, and submission execution.

· Coordinate preparation for regulatory meetings (e.g., pre‑IND, IND, and End‑of‑Phase 1).

· Ensure nonclinical, CMC, and clinical data packages are delivered on time and in compliance with contractual and global regulatory expectations.

Communication & Reporting

· Prepare and lead internal and external project updates, dashboards, and risk assessments with internal team members and government and other project stakeholders.

· Serve as a liaison with the government and other project stakeholders.

· Lead regular team meetings, ensuring clear action items and accountability.

· Deliver high‑quality written reports and presentations for government agencies and internal leadership.

Qualifications

Required

· Bachelor’s degree in life sciences, engineering, or related medical field

· 5+ years of project management experience in biotech/CRO/pharma.

· Demonstrated experience managing biopharma or government-funded (NIH/NIAID, BARDA, DoD, or similar) drug development preclinical and/or clinical contracts .

· Strong understanding of nonclinical development workflows (toxicology, pharmacology, ADME, virology, CMC).

· Proven ability to manage complex timelines, budgets, and multi-partner programs.

· Exceptional communication, organization, and stakeholder‑management skills.

· Comfortable working in a small, fast‑moving, resource‑lean environment, fostering accountability.

Preferred

· Experience conducting or managing IND-enabling studies and early clinical

· Experience with antiviral or infectious disease programs.

· Experience coordinating NIAID DMID-funded testing or development networks.

What We Offer

· A central leadership role in shaping program strategy and execution through preclinical and IND-enabling studies, and initial human clinical studies in a global health / U.S. defense medical countermeasure program.

· Collaborative, mission-focused culture with scientific rigor and operational agility.

· Competitive salary range of $115,000 – $139,000 based on experience and qualifications.

· Company incentive stock option plan.

· Health insurance coverage.

· 401k retirement savings plan with company matching.

· Paid time off and holidays.

Pay: $145,000.00 - $189,000.00 per year

Benefits:

401(k)
401(k) matching
Health insurance
Paid time off
Relocation assistance

Work Location: In person

Quick Apply

Refine Your Search

regulatory affairs jobs in oceanside ca

Project Manager / Senior Project Manager – Nonclinical Antiviral Development (NIAID Funded Program)

Consultant, Global Regulatory Affairs

Clinical Data Specialist II

Senior Director, Regulatory Affairs-CA

Associate Director, Regulatory and Medical Writer

Director, Program Management

Senior Project Manager - Associate Director, CMC

Senior Specialist, Product Performance, Medical Affairs

Quality Control Analyst

Clinical Scientist II

Senior Manager, Drug Safety

Senior Manager, Pharmacovigilance

Clinical Scientist

Director / Senior Director of Regulatory Operations

Director of Permitting

Vice President, Clinical Solutions Product Development

Supervisor, Quality Control Biology

Senior Packaging and Product Compliance Specialist

Regulatory Manager- IVD and 510(k)

Associate Director, Medical Writing

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