Tuesday, August 5, 2008

The Dearth Of Regulatory Affairs People In Japan

The Shortage Of Good Regulatory Affairs People In Japan Is A Major Headache For Pharmaceuticals And Medical Devices Firms.

  • The work involves a blend of medical expertise and an intimate understanding of Japanese regulation and the vast bureaucracy of the MHLW. A good regulatory affairs executive knows where to take risks, as well as where the regulator will give ground – and where it will not.
  • Regulatory affairs professionals tend to enjoy technical challenges, and their job only remains interesting if they are constantly challenged with new products.
  • Relationships are of critical importance in Japanese culture; if a regulatory affairs executive lacks relationships at headquarters, it may be difficult for them to speak up or they may start to look outside.

SOURCE:http://www.heidrick.com

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