• This executive role drives endtoend regulatory planning across the development lifecycle and serves as the companys senior interface with FDA, EMA, and other global health authorities
• Key Responsibilities Lead global regulatory strategy across CMC, Clinical, and NonClinical programs from early development through registration
• Oversee regulatory content and strategy for INDs, CTAs, meeting packages, NDAs/MAAs, labeling, and lifecycle management
• Provide strategic regulatory guidance to executive leadership and crossfunctional teams (CMC, Clinical Development, NonClinical, Medical, Safety, Biostats, Quality)
• Serve as primary liaison with global regulatory agencies to enable efficient and timely development

Build, mentor, and scale a highperforming Regulatory Affairs team; manage regulatory operations and external partners

• Qualifications 15+ years of broad regulatory affairs experience in pharma/biotech, covering CMC, Clinical, and NonClinical development pathways
• Proven track record of leading interactions with FDA/EMA and contributing to major global filings
• Exceptional leadership, communication, and strategic problemsolving skills
• Exceptional strategic thinking with the ability to navigate ambiguity and evolving regulatory landscapes
• Excellent communication and negotiation skills with regulators and internal stakeholders
• Executive presence with the ability to influence at all levels of the organization
• Strong organizational skills and the ability to manage multiple priorities simultaneously

Collaborative, transparent leadership style; committed to developing highperforming teams

Offer Base salary of $300-400K Opportunity to lead regulatory strategy for a dynamic, innovative midsized pharmaceutical company