Director/Sr. Director of Global Regulatory Affairs Lead
15000 人民币~20000 人民币/每月
全职
10年以上
刷新于 3 个月前
251 查看
49 申请
北京
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职位职责
Leads the GRT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders.
Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.
职位要求
Qualification Requirements:
Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree with at least 10 years of drug development experience. GRL experience in Oncology is a great plus.
Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.
Other Information/Additional Preferences:
Travel expected (10%)
Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan
Previous regulatory or leadership assignments across multiple countries
Industry-related experience in regulatory affairs and/or drug development experience for 10 years
Direct experience in clinical and CMC regulatory sciences
Experience in applicable therapeutic area (Oncology)
Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies
Strong written, spoken and presentation communication
Demonstrated negotiation and influence skills
Demonstrated attention to detail
Required Experience cont'd: Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.
Serve as a mentor for GRA personnel.
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