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Regulatory Strategist 

 
   
   

KEY TASKS AND 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 J-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.

 

 

WHO YOU ARE:

 

  • University Degree or above 
  • 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 preferred
  • Business English (TOEIC 730 or above) 
  • Fluent in Japanese 
  • PC skills (Microsoft Word, Excel, PowerPoint) 
  • Strong communication and collaboration skills  

 

The working location is either in Tokyo or Osaka.

 

 

 

   
Date of Employment: ASAP      
Division: Pharmaceuticals   Location: Osaka/Tokyo    
Functional Area: Regulatory Affairs   Position Grade: VS 1.1    
Employment Type: Regular  Work Time: 09:00 - 17:30  
 
 
Contact Us
 
E-Mail    

recruiter_jp@bayer.com

 

 
 

 

 
 
 

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