Job Description
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 inspections
Mentor and develop regulatory team members while driving continuou...
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 inspections
Mentor and develop regulatory team members while driving continuou...
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