药品注册【校园招聘】

Position Summary
Responsible for the regulatory affa******** submissions support fordMe******** its cl******** implementing drug registration operationservice support as per project nee******** such as IND, NDA, lifecyclesubmissions an******** authority query response, as well as thesubmissions-relate********. Maintain goo******** with regulatoryauthorities for business support. Keep apprise******** regulatorydevelopments an******** key regulatory changes locally an********.Contributing to dMe******** regulatory intelligence ********documentation system an******** program, supporting businessopportun******** etc.

Key Responsibilities
- Ensure require******** support for dMe******** its cl********implement drug registration strategy plan or operational service as perproject and/or customer’s needs
- Establish an******** goo******** with regulatory authoritiesan******** associations for business support an******** key regulatory changes
- Contribute to dMe******** regulatory intelligence ********documentation system an******** program, consultation an******** tobusiness opportun******** etc.

Education an******** Competency Requirements
- Master degree in a life or medical sciences or relevant scientific background.
- Knowledge of ICH Gu******** local regulations an******** ******** butnot limite******** regulatory requirements for the conduct of clinicaldevelopment programs.
- Superb organ******** communication skills (oral an******** in Chinese& English) an******** interpersonal skills to be able to effectivelyinteract with customers, key stakehol******** health author********multidisciplinary groups as well as with vendors.
- Goo********, analytical an******** identification ab********an******** to detail
- Creative problem solver an******** ability to address currentan******** issues
- Goo******** spirit an******** working attitude
- Proficient computer skills