Director

1. Strategic Planning & System Development Establish and optimize the institute’s R&D management systems, including project management, IP management, registration affairs, and R&D quality control systems. Lead process R&D for Active Pharmaceutical Ingredients (API) and formulations, as well as quality research and Consistency Evaluation (CE), ensuring compliance with NMPA, FDA, EMA, and other global regulatory standards. 2. Innovative R&D & Technological Advancement Lead teams in the development of small-molecule New Chemical Entities (NCEs), high-end generics, and 505(b)(2) drugs. Spearhead technical breakthroughs in complex formulations (e.g., sustained/controlled release, microspheres, liposomes) and specialty APIs, driving successful tech-transfer to manufacturing. Monitor global pharmaceutical frontiers and promote the application of advanced technologies such as green chemistry, continuous flow reaction, and biocatalysis. Oversee organizational structure design, recruit high-level R&D talent (domestic and overseas), and build an internationally competitive R&D team. Establish scientific performance evaluation and incentive mechanisms to cultivate core technical backbones and enhance overall R&D efficiency. Manage the annual R&D budget, optimizing resource allocation to control costs while maximizing output. 4. External Collaboration & Registration Affairs Develop regulatory strategies and serve as the primary liaison with regulatory agencies (e.g., CDE/NMPA) to ensure smooth approval processes. Expand strategic partnerships with universities, research institutes, and CROs to build an open innovation ecosystem. Lead the application and execution of major government science and technology projects (e.g., National "Major New Drug Innovation" Programs). II. Qualifications 1. Education Ph.D. in Medicinal Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Engineering, or related fields. Postdoctoral experience or overseas R&D experience in renowned pharmaceutical companies/institutions is highly preferred. 2. Experience 10+ years of experience in pharmaceutical R&D; 10+ years in R&D management/leadership roles. Demonstrated success in leading at least 2 products through the full lifecycle from IND to NDA/BLA approval. Technical Expertise: Proficient in synthetic route design, process optimization (DOE), analytical method development/validation, and formulation studies. Regulatory Mastery: Deep understanding of ICH guidelines, China GMP, and EU/US cGMP regulations; extensive experience in CTD dossier compilation and regulatory communication. #J-18808-Ljbffr Zhejiang Zongheng Human Resources Co., Ltd.