Job Description

As a Regulatory CMC Manager, required to possess specialized knowledge and experience in Japanese CMC regulations. Would be responsible for formulating CMC regulatory strategies and handling approval applications for Viatris’ development products (both generic and new drugs). Additionally, required to manage CMC change control for existing products and conduct due diligence for new products as a CMC regulatory representative. By collaborating with both Japanese and global teams, This position is expected to contribute to projects as the CMC regulatory representative, aiming to deliver Viatris products to patients as quickly as possible.

Required Skills and Knowledge

BA degree or above
Over 5 years of experience in writing the CTD Quality sections (M2.3S and M2.3.P) for pharmaceuticals (both generic and Brand Products).
Business-level proficiency in English and Japanese