Compliance

• Develop global, integrated regulatory strategies for assigned products with patient-centric focus.
• Act as key GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams and lead GRAST.
• Directly lead health authority interactions in stationed country (FDA or EMA) and maintain relationships with FDA, EMA, and global authorities.
• Engage and assign tasks to GRAST members to achieve regulatory deliverables and act as regulatory decision maker/approver.
• Review and approve deliverables (e.g., protocol, TPP) from PST, CDT, SMT and related teams; lead discussions at Global Regulatory Forum and with senior management.
• Lead GRA project deliverables (e.g. Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members.
• Leverage regulatory intelligence/AI, business insights/analytics, and specialized regulatory functions to deliver Global Regulatory Strategy Outlines.
• Foster effective relationships across Global Regulatory Strategy, GRAS Regions and Regulatory CMC, promoting consistency and shared learnings.
• Report to Executive Director Head Regulatory; onsite three days a week in King of Prussia, PA or Zurich, Switzerland office.

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