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Regulatory Affairs, CMC
25-45K/月上海市-上海/本科及以上/经验不限
陈文贇6天前来过
百时美施贵宝（中国）投资有限公司
职位详情
岗位职责
• Ensure regulatory compliance with government policy and company required SOPs
• Develop the regulatory CMC strategy of assigned products based on local regulatory requirements, ensure local regulatory strategy is aligned with TA strategy and consistent with global product strategy and local priorities
• Develop and maintain the good life cycle management plan of assigned products and timely communicate with internal and external key stakeholders to allocate of adequate resources and deliver plans on time
• Ensure good execution for product lifecycle management including renewals, variations and other registration/commercial activities through timely submission and approval with a high standard
• Identify risk areas and develop alternative sources of action, including anticipation of regulator responses through scenario planning and contingency plans.
• Monitor external changes in the regulatory environment that will impact on the CMC requirement, timely communicate the impact of changes to key stakeholders
• Maintain strong working relationship and communications with internal and external key stakeholders.
• Establish and maintain close relationship with NMPA/ CDE/ NICPBP and other appropriate regulatory agencies and have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to NMPA.
• Develop the regulatory CMC strategy of assigned products based on local regulatory requirements, ensure local regulatory strategy is aligned with TA strategy and consistent with global product strategy and local priorities
• Develop and maintain the good life cycle management plan of assigned products and timely communicate with internal and external key stakeholders to allocate of adequate resources and deliver plans on time
• Ensure good execution for product lifecycle management including renewals, variations and other registration/commercial activities through timely submission and approval with a high standard
• Identify risk areas and develop alternative sources of action, including anticipation of regulator responses through scenario planning and contingency plans.
• Monitor external changes in the regulatory environment that will impact on the CMC requirement, timely communicate the impact of changes to key stakeholders
• Maintain strong working relationship and communications with internal and external key stakeholders.
• Establish and maintain close relationship with NMPA/ CDE/ NICPBP and other appropriate regulatory agencies and have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to NMPA.
任职要求
无
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公司信息
百时美施贵宝（中国）投资有限公司
- 上海
- 100-499人
- 生物制药、临床医疗服务
- 外企
- 不需要融资
百时美施贵宝公司是一家从事医药及相关保健产品生产的全球性企业，它的使命是＂延长人类寿命，提高生活质量＂。目前的主要业务包括中美上海施贵宝制药有限公司（SASS），美赞臣（广州）有限公司和百时美施贵宝中国肿瘤药物部。在中国现有员工约1,500人，有40多个知名品牌的药品、营养品和医疗器械在中国市场推广。百时美施贵宝中国肿瘤药物部于1992年正式成立。这十年来，百时美施贵宝优秀的抗癌药物和公司在肿瘤治疗领域的国际领先地位已被中国的肿瘤专家和社会公众所认识。目前，近50位医、药专业的营销人员在全国各主要城市进行总公司产品的介绍和推广。关于公司的更多信息，请浏览网站。为了满足公司业务的快速增长，我们欢迎有才之士与我们一起共创未来。
