Regulatory Affairs Manager, Beijing

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Job Description

OBJECTIVES/PURPOSE

• In accordance with the company’s product launch strategy, lead and coordinate the process of drug registration and ensure the compliance of technical documentation and process to guarantee the success of drug registration.
• Complete related registration work of established product during the registration cycle to ensure the continuous effectiveness of Import Drug License.
• Keep close coordination with internal and external stakeholders.

ACCOUNTABILITIES

• In accordance with the company’s product launch strategy and department’s work plan, take full responsibility of the product registration and application for approval and develop the plan by stage. Contribute to decision making on drug registration leading to minimal registration timeline.
• Guide subordinates to solve the problems occurred during drug registration in uncertainty Chinese pharmaceutical environment to achieve drug registration approvals in timely and cost effective way.
• Summarize product registration related materials with coordination among head office, factory, Sales & Marketing. Provide corresponding support for the sales in China market.
• In accordance with the plan of product registration and application for approval, manage the necessary materials and information during the process and track and summarize the progress.
• Be responsible for submission of complete and qualified product application data to drug regulatory authorities, coordination of raw data review and on-site assessment.
• Manage and archive examination and registration materials and other relevant documents.
• Provide necessary support to the preparation and implementation of clinical trial.
• Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as SFDA, CDE, NIFDC, PIDC and etc. Monitor regulatory environment and collect important information such as regulations, guidelines, competitive products and etc.
• Establish and maintain internal/external channels of communication.
• Ensure regulatory activity is in compliance with authority and Takeda policy.
• Coordinate with the establishment of internal SOP and system.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Has drug regulatory experience and be familiar with Chinese registration regulation

Leadership

Has strategic thinking and excellent communication skill

Decision-making and Autonomy

Has problem solving capacity and provide professional proposal when face complex business situtation

Interaction

Keep close interaction with internal and external stakeholders, including but not limited GRA, CBU, NPD, TDC-A, GPT, SWR, GRT, TJT Factory, GMS, GQ etc. and NMPA, CDE, NIFDC, ChPC, RDPAC, CCFDI etc.

Innovation

Has professional insight and would like to take risk based on professional evaluation

Complexity

Has international cultural awareness and has good collaboration with global colleagues

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Bachelor Degree or above majored in medicine or pharmacy.

>5 year related work experience.

Skilled in using computer office software.

Good English in listening, speaking, reading and writing.

Excellent communication skill and leadership.

Be familiar with the laws and regulations of drug administration and registration management, stronger professional competency.

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