Josephine Peng

Regulatory Compliance Manager

Shenzhen Youme Information Technology Co., Ltd • Tiempo completo

Jul 2019 - Present • 6 yrs 10 mos

Lead global regulatory strategy for electronic cigarette products, with a primary focus on U.S. PMTA submissions and international market access. Develop and maintain a global regulatory intelligence map to monitor evolving requirements across key markets. Oversee compliance operations, including regulatory agency correspondence, internal training, and audit readiness. Manage product certification and national tobacco product registration in China Served as a core PMTA project lead, translating FDA guidance into internal implementation plans. Conducted supplier evaluation and traveled to the U.S. to select clinical, laboratory, and consulting partners. Built and implemented a QSR 820-compliant quality system, authoring and reviewing over 30 system documents. Established a Design History File (DHF) system and managed technical documentation for PMTA submissions. Coordinated a product transfer project, reviewing over 300 production documents. Led a successful FDA remote inspection, coordinating 12 departments and preparing 300+ audit files. Managed deficiency letter responses in collaboration with external regulatory consultants. Oversaw Middle East product registration, contributing to the region becoming the company’s second-largest market and achieving the No. 1 brand presence locally.