SUMMARY:
Fortvita Biologics is seeking a Director/Sr. Director of Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). Leads the Global Regulatory Team. Serves as the primary regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development, regulatory requirements, Develops and implements accelerated submission strategies.
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