Project Manager Global Regulatory Affairs

We're seeking an experienced Regulatory Affairs Global Project Manager to lead our regulatory strategy and submissions across multiple global markets. This is a high-impact role where you'll bridge global regulatory teams, manufacturing operations, and cross-functional stakeholders to drive successful product approvals for life-changing therapies.

What You'll Do

• Lead global regulatory strategies for cell & gene therapies, biosimilars, and biologics across FDA, EMA, PMDA, and other jurisdictions
• Manage complex regulatory projects from IND/CTA to BLA/MAA submissions and post-approval lifecycle management
• Drive cross-functional collaboration with R&D, Quality, Manufacturing, and Clinical teams globally
• Ensure CMC compliance for advanced therapy manufacturing processes and tech transfers
• Navigate health authority interactions including pre-submission meetings, information requests, and inspect...