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Regulatory Affairs (Manager - Senior Manager)

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Published:   2022/09/21

Type

Full time

Category

Pharmaceuticals

Salary

¥ 13,000,000 Yearly ~ ¥ 15,000,000

Education

BS

Required language

English: Business

Description

Position: Regulatory Affairs (Manager - Senior Manager)

  • Tokyo or Osaka
  • Salary range: 13 - 15M

Company Overview

Our client is a multinational mega-pharmaceutical company headquartered in Europe, with therapeutic area focus in cardiovascular, gastrointestinal, neuroscience, oncology and immunology.

Position Overview

Due to some internal reorganisation, a new senior role has opened within the Regulatory Team, and will include a selection of key Responsibilities, including:

  • Developing and executing regional RA strategies
  • Contributing to global regulatory strategies/plans and closely cooperating with local Health Authorities regarding new drug applications or relevant change applications 
  • Interacting with the related Global Regulatory Leads to manage and resolving cross-functional issues
  • Leading PMDA consultation, NDA and supplemental NDA filings teams for successful consultations, filings and timely approval

This position has two potential pathways. If you would like to move into people management, this can be assigned (and therefore career path towards a natural successor for the current RA Head). However if you prefer to function as a standalone contributor, that is also fine.