Director of Regulatory Affairs

Director, Regulatory Affairs Strategy

About the Rol

eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical pipeline. This individual will serve as the primary regulatory strategist for one or more development programs, partnering closely with cross functional teams to drive programs from IND through approval. The role offers significant visibility with senior leadership and the opportunity to shape regulatory direction for novel therapeutics

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Key Responsibiliti

• esDevelop and own global regulatory strategies for assigned programs, including US, EU, and key international marke
• tsServe as the regulatory lead on cross functional program teams, providing strategic guidance on study design, endpoints, and development pathwa
• ysLead preparation and execution of health authority interactions, including pre IND, End of Ph...