VP, Regulatory Affairs

Role: Vice President of Regulatory Affairs responsible for strategic and operational oversight of regulatory activities in biopharma product development. Objectives include developing and executing regulatory strategies, ensuring compliance, and managing submission plans for preclinical, clinical, and post-approval stages. Responsibilities encompass leading a regulatory team, guiding cross-functional groups, preparing for FDA and global authority meetings, managing regulatory filings (e.g., INDs, BLAs, NDAs), and maintaining regulatory intelligence on global standards. The role involves direct interaction with regulatory agencies, representing regulatory interests in leadership forums, and managing risk communication. Qualifications: PhD or master's degree with relevant experience; 15+ years in regulatory affairs within biopharma, with expertise in drug development processes, global regulations, and CMC considerations. Preferred skills include knowledge of small molecule regulations, international submissions, and familiarity with Chinese regulations. High-Value: leadership in regulatory strategy, extensive industry experience, global regulatory knowledge, expertise in pharmaceutical development and manufacturing. Work setup and travel requirements are not specified.