Job number: JN -072024-142574 Posted: 2024-09-11

Regulatory Strategist

RA
8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

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
Martin Tsvetkov
BRS Consultant
Martin Tsvetkov
Pharma
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