Senior Manager, Regulatory Affairs

Role: Senior Manager, Regulatory Affairs at Vericel, managing complex regulatory projects independently across biologics and combination products in cell therapies for sports medicine and burn care. Responsibilities: develop regulatory strategies, oversee IND/BLA submissions, assess regulatory risks, respond to health authority inquiries, and serve as a regulatory expert on cross-functional teams. Requirements: 8+ years in biotech/pharma regulatory roles supporting biologics, with experience in BLA preparation, FDA regulations, and eCTD structure; strong regulatory writing and communication skills; BS in a scientific discipline, advanced degree preferred. High-Value: biologics, combination products, IND/BLA phases, FDA interactions, biologics/biotech focus, cross-functional leadership, remote work with occasional travel. WorkSetup: onsite Mon-Thu in Burlington, MA, with remote Fridays.