Bioinformatics Institute of India

Blog of BII an Institute having thousands of program participants from more than 40 countries. BII is the training leader in emerging life science and pharma domains.The Blog Members are encouraged to share news, views, jobs, comments, with others. All the members (students, alumni, non students) are encouraged to Post and comment to the Blog. Blog focus is on Bioinformatics, Biotechnology, Pharma Regulatory Affairs, Clinical Trials, Drug Design and Discovery, IPR, GMP

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