求人番号:JN -072024-142574 掲載日:2024-09-11

Regulatory Strategist

RA
800 - 1200 万円 東京 製薬 薬事

募集要項

会社概要
同社は、ヨーロッパに本社を置く国際的な薬事関係企業です。
業務内容
  • 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
応募条件
  • 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
給与
800 - 1200 万円
勤務地
東京
Martin Tsvetkov
BRSコンサルタント
Martin Tsvetkov
Pharma
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