Principal Scientist, Regulatory Affairs – CMC

State of Oregon is hiring a full-time Principal Scientist, Regulatory Affairs - CMC to join its team on-site in Jersey City, Hudson County. This is a leadership opportunity for a regulatory expert ready to shape Chemistry, Manufacturing & Controls strategy across a global medicine portfolio.

About the Role

As Principal Scientist and Team Lead, you will steer Regulatory Chemistry, Manufacturing & Controls (CMC) direction for the General Medicine portfolio. Reporting to the Executive Director who heads this portfolio, you will set the strategic course for CMC submissions and serve as a senior point of authority guiding both project teams and regulatory decisions. While one or more candidates may already be under consideration, State of Oregon welcomes applications from every qualified professional who is interested in this position.

Key Responsibilities

• Provide strategic Regulatory CMC leadership across the General Medicine portfolio.
• Act as Team Lead, coordinating CMC regulatory activities and aligning cross-functional contributors.
• Partner with the Executive Director and senior stakeholders to define and execute CMC regulatory plans.
• Translate complex manufacturing and controls data into clear, compliant regulatory strategy.
• Support the preparation and advancement of high-quality regulatory submissions.

Qualifications

• Deep expertise in Regulatory Affairs with a focus on Chemistry, Manufacturing & Controls (CMC).
• Demonstrated experience leading or guiding regulatory project teams.
• Strong scientific background suited to a Principal Scientist-level role.
• Ability to develop and communicate regulatory strategy across General Medicine programs.
• Availability to work full-time on-site in Jersey City, Hudson County (this position is not remote).

About State of Oregon

State of Oregon offers a setting where regulatory science professionals can take ownership of meaningful portfolio leadership. In this role, your CMC insight will directly influence how medicines move through the regulatory landscape.

How to Apply

Ready to lead as a Principal Scientist, Regulatory Affairs - CMC with State of Oregon in Jersey City? View the full listing and submit your application via Adzuna.