Regulatory Strategist

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Job details

Company overview

Our client is one of the most well-established European-based international pharmaceutical companies in Japan.

Responsibilities

• Build a registration strategy for efficient product development in Japan to get fast approval of new projects (new product, new indication, new dose & administration, new formulation, etc.).
• Coordinate the relevant functions to prepare the documents which should be submitted to PMDA and/or MHLW such as the documents relevant to PMDA consultation and Orphan Drug Designation.
• Support the dossier manager to lead the relevant functions to prepare the required documents for NDA/sNDA submission and answer documents to inquiries during NDA/sNDA review by PMDA, and conduct the following activities.
• Ensure other functions to prepare the documents to be submitted to Health Authority on products.
• Contribute to the global regulatory activities on projects in charge by inputting regulatory strategy in the global regulatory strategy.
• Provide Global Regulatory Team (GRT) with the Japanese legal/regulatory requirements and Japanese development strategies if necessary.Graps the regulatory information such as HA’s movement, legal requirement on NDA/sNDA guidelines, etc

Requirements

• At least 5 years experience as a regulatory strategist
• Experience negotiating with PMDA in a must
• Someone with cell and gene therapy product development is preferre

Salary

8 - 12 million yen

Location

Tokyo