上海亚虹医药科技招聘

职位描述：

• GMP
• QC
• FDA
• 新药注册
• 进口药品注册
• 仿制药注册

1） In charge of all Small Molecule CMC regulatory relevant activities of assigned new products (IND/CTA/NDA, Variation, and renewal), including CMC strategy making and implementation, CMC document preparation, CDE CMC technical review follow up, HA CMC meeting or communication for CMC topics, QC testing, GMP on-site inspection, ChP, bundling review, etc. 2） Provide strategic and technical regulatory CMC input and support to line manager to contribute for decision making on new drug CMC development strategy and license maintaining CMC strategy to deliver the highest value to business. 3） Independently compile high quality CMC filing document complying with external and internal requirement to provide right and clear drug profile and data to HA to achieve targeted labeling and drug features to be approved. 4） Independently engage with internal and external CMC stakeholders to follow up every CMC milestone closely to ensure issue identified, escalated, resolved timely and target CMC filing and approval timeline plan is achieved. 5） Establish and maintain a good relationship with key CMC regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc via professional communication. 6） Make sure line manager fully informed CMC projects registration status in daily work. 7） Support line manager on budget planning and monitoring for CMC projects in daily work. 8） Provide timely and high quality CMC regulatory support and input to internal key stakeholders such as clinical, medical and commercial as needed. 9） Significantly contribute or lead function continuous improvement initiative 10）Ensure timely and flawless implementation of company SOP and compliance requirement in daily work. Qualifications/Requirements: 1） A minimum of bachelor degree in Chemistry or biological or pharmacy 2） Minimum 8 years experience in regulatory affairs field 3） Primary focus on small molecule, experience in biologics as plus 4） Proven ability to communicate (written/oral) with various functions and with authority 5） Fluency in English Ability of cross functional co-operation. 6） Strong ownership and cross boundary working mindset 7） A strong capability in problem solving 8） Strong ability of lobby, influence and negotiation

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上海亚虹医药科技 · HR