Description
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Job Description
Responsibilities:
1.Regulatory Strategy for new products & life cycle management: leads the therapeutic area regulatory strategy team to secure timely regulatory approvals of new products, and post-approval variations by developing innovative approaches, including providing regulatory inputs in a timely manner to de-risk drug development to support successful product launches
2.Analyze and compare regulatory outcomes against initial product concepts; offer recommendations for future strategies and continuous improvement.
3.Registration maintenance: responsible for managing the product life cycle, upholding rigorous compliance to maintain product licenses.
4.Assists to advance the organization’s approach to incorporate China regulatory requirement in an efficient and forward looking matter into drug development and product life cycle, anticipating potential regulatory challenges and emerging issues, and addressing them swiftly.
5.Internal Stakeholders Management: builds and maintains strong trusting relationships with internal stakeholders including global, regional and local functions to enable teams to deliver the pipeline. Engages effectively with all levels of management, including senior leadership, often coordinating cross-functional activities on high-impact initiatives.
6.External Stakeholders Management: Assists to build and sustain influential relationships with key regulatory authorities - including NMPA, CDE, NIFDC, ChP, and other relevant stakeholders - to advance organizational objectives and promote regulatory excellence.
7.Proactively identify the need for new and updates to regulatory policies, processes, and SOPs; provide final approval, whenever needed, and ensure policies foster a culture of compliance and operational excellence. 8.Responsible for compliance with applicable China and Divisional Policies and procedures.
9.Partners with Therapeutic Area Regulatory Strategy Heads to foster a culture of high performance, fast adaptability to change, collaboration, and team spirit - empowering team members to achieve ambitious goals, share best practices, and support each other in delivering exceptional results.
10.Partners with Therapeutic Area Regulatory Strategy Heads to set quality and accuracy standards across regulatory strategy, collaborating with management and stakeholders to devise effective solutions for complex challenges.
11.Represents the organization in external industry working groups, shaping advocacy efforts in alignment with business strategies.
12.Leads project teams or initiatives within and across departments, delivering technical expertise and strategic direction to advance business priorities.
Education and Competencies (Technical and Behavioral):
Bachelor’s degree or above majored in medicine or pharmacy
Typically, 15 years of related work experience in regulatory affairs, including 5 years of experience in people management and well-developed skills in teambuilding, motivating, empowering and developing people
Regulatory Knowledge: In-depth knowledge of local regulatory requirements. Ability to identify and communicate country-specific requirements.
Strategic Thinking: demonstrates strategic thinking by breaking apart complex challenges to develop innovative solutions. Proven ability to lead and inspire cross-functional teams, with excellent project management and organizational skills.
Problem-Solving: demonstrates ability to think strategically, analyze complex issues, and develop innovative solutions.
Communication: Strong written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.
Cultural Competence: Experience working in a global environment, with an understanding of cultural differences and regulatory nuances.
Locations
Beijing, China
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time