OVERALL OBJECTIVE OF THE JOB:
Responsible for biomerieuxs regulatory affairs in P.R.China


Responsibility:
1.Ensure that the registration is complete within the normal schedule before a product is officially launched into the market;
2.Responsible for co-ordinating the registration dossiers preparation (translating, notarising, legislating according to the requirements of SFDA). No rejection when submitting the dossiers;
3.Responsible for co-ordinating the preparation of Chinese package inserts and package labels for new products;
4.Urging, pushing and co-ordinating in each step of the registration, make sure that the steps would be finished within SDAs standard time limit, no delay in each steps;
5.Responsible for arranging the clinical trials and equipment quality checking and quality control method checking, speed up the time period of these trials;
6.Responsible for making suggestions towards which products should be registered according to marketing situation and company strategies;
7.Setting up the warning system for renewal of the registration certificates and make sure all the certificates should be renewed before reaching the expiry date;
8.Responsible for reporting to and updating the corporate regulatory affairs department about the status of product registration and impact of new regulatory policies on bioMerieux products;
9.Responsible for updating the subsidiary management and distributors about the status of new product registration;
10.Provide legal advice on new projects;
11.The priority of regulation is given by the marketing team
12.To ensure the coordination with Corporate R/A Department

Qualification:
1.Strong responsibility
2.Carefulness & Method & Seriousness
3.Quick responses
4.Bachelor degree or above
5.Knowledge and experience in medical field and registration field for 3 years or more
6.Good interpersonal skills
7.Good at both spoken and written English
8.Work under pressure