Senior Manager- China Regulatory Affairs CMC & Device

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Job Description

About the role:
The Senior Manager CMC Regulatory Affairs is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, and for maintaining the currency of product licenses and permits. This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of bringing Better Health to people and a Brighter Future to the world.

How you will contribute:
* Ensure the organization is aware of and compliant with legislation and regulations pertaining to the business
* Monitor and interpret regulatory developments and determine the impact on business operations and compliance programs
* Implement compliance strategies and policies for short-term results
* Prepare, review, and approve regulatory compliance documents
* Manage a medium-sized team of managers, supervisors, professionals, and specialists
* Engage with internal and external stakeholders at various management levels and present findings at meetings
* Oversee projects, budgets, schedules, and performance standards

Skills and qualifications:
* Applies advanced change control techniques, capable of handling complex situations independently and coaching others
* Manages tasks requiring high attention to detail, addresses complex scenarios independently, and advises others on precision
* Leads new product development projects, advising on market analysis and customer needs, manages complex situations
* Advanced proficiency in biotechnology, applies knowledge in complex situations and advises others on biological processes
* Capable of performing complex clinical trials independently, provides recommendations for improvements
* Navigates and improves drug development processes, provides guidance in complex scenarios
* Fully independent in influencing others, applies advanced techniques in complex situations
* Fully adept in Good Manufacturing Practices, handles highly complex situations and mentors others
* Applies biology knowledge in complex situations, makes improvement recommendations
* Leads lifecycle management efforts in complex projects, provides recommendations for improvements
* Excels in verbal communication, articulates complex concepts clearly and adapts messaging for various audiences
* Provides leadership and strategic guidance to a medium-sized team, acting as an advisor and trainer

As a leader of a department, you oversee a medium-sized team of managers, supervisors, or professionals and specialists working on diverse topics. While actively involved in daily operations when necessary, You will also provide strategic guidance, act as an advisor and trainer to your team, and make decisions guided by the sub-function business plans. Your responsibilities include managing projects, budgets, schedules, and performance standards, as well as engaging with internal and external stakeholders at various management levels and presenting findings at meetings.

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