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Regulatory Affairs Manager, Beijing

2 months ago

Beijing, Beijing, China Takeda Full time
Job Description

Job Title: Regulatory Affairs Manager, Beijing

Job Summary:

We are seeking a highly skilled Regulatory Affairs Manager to join our team in Beijing. The successful candidate will be responsible for managing the product registration and application process, ensuring compliance with regulatory requirements, and providing technical leadership to the business.

Key Responsibilities:

  • Develop and implement product registration and application plans, ensuring timely and compliant submissions to regulatory authorities.
  • Lead cross-functional teams to coordinate product registration activities, including data review and on-site assessments.
  • Establish and maintain relationships with key regulatory authority individuals and KOLs, monitoring regulatory environments and collecting important information.
  • Ensure regulatory activities are in compliance with authority and Takeda policy, coordinating with the establishment of internal SOP and system.
  • Provide technical leadership to the business, summarizing product registration related materials and providing corresponding support for sales in the China market.

Requirements:

  • Bachelor's degree or above in medicine or pharmacy.
  • More than 7 years of related work experience.
  • Skilled in using computer office software, with good English or Japanese language skills.
  • Familiar with laws and regulations of drug administration and registration management, with stronger professional competency and excellent communication skills.

Location: CHN - Beijing - Research and Development

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time