Vice President, Regulatory and Head of Regulatory Affairs

Role: Vice President of Regulatory and Head of Regulatory Affairs, responsible for shaping and executing regulatory strategies to support clinical development and ensure compliance for Sagimet. Responsibilities: develop comprehensive regulatory plans aligned with product lifecycle and business goals; lead IND, NDA/BLA, MAA, CTA, and other regulatory filings ensuring high quality and timely submissions; serve as primary liaison with global agencies (FDA, EMA, NMPA, PMDA), managing communications and negotiations; oversee external regulatory vendors; collaborate with clinical, R&D, and quality teams to provide regulatory guidance and identify risks. Requirements: advanced degree (Ph.D., PharmD, MD preferred); minimum 15 years in biotech/pharma regulatory affairs with successful IND/NDAs; deep expertise in US and international regulatory systems; strong project management and communication skills; proficiency with regulatory submission tools. Preferred: experience in publicly traded biotech firms. HighValue: global regulatory strategy, IND/NDA/BLA submissions, agency interactions, cross-functional collaboration, senior leadership. WorkSetup: not specified; salary range $340K-$370K based on experience.