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.
• 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.