Regulatory Affairs CMC Manager

Location: Tokyo, Japan Salary: ¥9000000 - ¥12000000 per annum + competitive
Sector: Regulatory Affairs Type: Permanent

Seeking a Regulatory Affairs CMC Manager to join the company to provide strategy and leadership to global CMC activities. You will join an international team, offering a flexible working environment and a very good work-life balance. The company supports global initiatives, promotes career satisfaction and offers opportunities for development and career advancement within the company.

Innovative Global Biotechnology Company with products to market and a strong and exciting development pipeline. The company is focused on patients and people and values the discovery of innovative therapies in the healthcare industry. Offers a great work-life balance and a diverse and flexible company culture.

As an RA CMC Manager, you will be involved in the following:

  • Supporting NDA submissions (Module 2.3, Module 1.2 and Module 3)
  • Responding to PMDA
  • Quality check of CMC-related documents
  • Provide RA CMC knowledge and leadership to the team

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