Regulatory Affairs Program Manager

A publicly traded, commercial-stage biopharmaceutical company is developing next-generation immunotherapies designed to harness the body's own immune system against cancer and infectious disease. Their lead product - an FDA Breakthrough Therapy for non-muscle invasive bladder cancer - is already changing outcomes for patients. They're now looking for a Regulatory Affairs Program Manager to help drive the next wave of approvals.
What you'll do:
• Lead cross-functional regulatory programs from strategy through execution — setting timelines, milestones, and risk-mitigation plans
• Act as the regulatory point of contact across R&D, Clinical, Quality, Manufacturing, and Commercial
• Track regulatory intelligence and translate changing global requirements into clear, actionable strategy
• Own SOPs and process standardization, and report program status to senior leadership
What you'll bring:
• Bachelor's degree in sciences, business, or project management, with 5+ years of progressive experience
• 4+ years in regulatory affairs within pharma, biologics, or medical devices (preferred)
• 3+ years managing complex, multi-regional regulatory programs (preferred)
• Strong cross-functional collaboration skills and a track record of delivering on schedule

This is a chance to join a publicly traded biopharma company at a pivotal growth stage - working at the intersection of science, strategy, and execution to bring transformative therapies to patients faster.