DRA Manager

Duties and Responsibilities :
 -       Import project registration strategy making: takes major responsibility starting from SOD to minus 18 months prior to 1st Phase III FPI for NCE:

•  By interact with RCC and corporate study team, work out the high level regulatory strategy and decide the regulatory pathway for early drug registration. 
•  Strategy document maintenance during the specified period.
• Share with TA groups monthly the NCE pipleline status and updated strategy.
• Chair the regulatory strategy challenge meeting.
•  Transfer the job to sub-team DRA in TA group minus 18 months prior to 1st phase III FPI.
•  As consultant to TA groups after job transfer till NDA filing.
•  Pan-Asian phase I strategy.

-       Work on SOPs, monitor the implementation, internal regulatory quality assurance to identify continuous improvement opportunity.

-       Training the local RA team on specific local topics for standardisation of processes, forms to be used locally etc.
 

Qualifications:
 -       Minimum bachelor degree in pharmacy, medicine or other life sciences.
-       Working experience in drug regulatory function, preferably more than 8 years.
-       Good negotiating skill with health agencies.
-       Good leadership and teamwork skills.
-       Fluency in English.