(CW) Regulatory Affairs Manager

Job Title: (CW) Regulatory Affairs Manager
Location: Novato, CA | Remote or Onsite (San Rafael)
Hours/Schedule: Full-time; schedule based on project needs
Compensation: $73 – $76/hr
Type: Contract

Overview

A leading biotechnology organization focused on innovative global therapeutic development is seeking a Regulatory Affairs Manager to support their nonclinical and clinical regulatory programs. This role is essential in shaping regulatory strategy, preparing global submissions, and ensuring compliance throughout the product lifecycle. If you’re looking to contribute to science that impacts patients worldwide, this is an exciting opportunity.

Responsibilities

• Support development and execution of global nonclinical/clinical regulatory strategies, ensuring alignment with overall program goals.

• Prepare, coordinate, and deliver regulatory submissions (INDs, CTAs, NDAs, BLAs), including high-quality nonclinical/clinical content and required documentation.

• Lead or support preparation for Health Authority interactions, including planning, meeting materials, briefing documents, and follow-up activities.

• Collaborate with cross-functional teams, CROs, Regulatory Operations, and Regulatory Project Management to align timelines and ensure submission readiness.

• Maintain and organize regulatory records, including IND maintenance, administrative documentation, dossier updates, and archiving of submissions and correspondence.

• Stay current on regulatory guidelines, review study-related documents as needed, and ensure accurate tracking of timelines and deliverables.

Requirements

• Degree in health or life sciences (Chemistry, Molecular Biology, etc.).
• 4 years of Regulatory Affairs experience.
• Experience in nonclinical and/or clinical regulatory strategy preferred.
• Strong understanding of IND/CTA processes, HA submissions, and regulatory guidelines.
• Ability to collaborate cross-functionally and manage multiple priorities.
• Excellent organizational, communication, and documentation skills.
  

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.



System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.



Ref: #568-Clinical