RD-Regulatory Affairs Manager-Guangzhou

JOB PURPOSE:

•Effective performance of key accountabilities ensures new registrationan******** LCM maintenance of markete******** in China Region;
•Ensure quality an******** of regulatory activities in the China region;
•Be responsible for regulatory risk assessment an********


KEY ACCOUNTABILITIES:

•Contribute an******** regulatory strategy for the responsible projectswith the guidance of senior regulatory manager ◦Work with relate********at GRA an******** region to develop an******** the regulatory strategyof the responsible projects for the China reg******** aligne********global strategy an******** regional business strategy
◦Regulatory supports for the relate******** in the China region
◦Collaborate with relate******** at corporate, IA an******** withaffiliatesproject team to support the regulatory activities in theChina region



•Be accountable for HA interaction for regulatory strategy assessmentwith the guidance of senior regulatory manager ◦Work across project teaman******** relate******** to evaluate, Dossier gap assessment,Regulatory pathway an********, RA compl******** Implication of thefindings on the deal terms, Ways to mitigate identifie********,implications on cost / time etc.
◦Align an******** recommendations across RA organization (global,regional) an******** the same in format as requeste******** integrate inthe final internal documents (DD reports, management presentat********AIF etc.)
◦RA partner for BD on strategic projects an******** mapping
◦Alert the new regulations issue******** NMPA、CDE、NIFDC an********,Uupdate key changes in regulations an******** implications
◦Inputs for strategic projects on RA regulat******** re******** trends



•Be accountable for the regulatory strategy implementation by CTA /NDABLA submission / approval
•Be accountable for the LCM mantainance of markete******** product inChina an******** regulatory support for NIFDC testing to securecommercial supply
•Lea******** operations for the assigne******** in China◦Work withrelate******** in China to support business timely
◦Regulatory support to other fuctions
◦Ensure regulatory compliance an******** in compliance way
◦Regulatory support to local production in Shenzhen site