Tracy (Ting) Du Email and Phone Number

Manage a group of 20 people to support global regulatory compliance activities. Tracking and reporting the LRAM regulation action and provide guidance via information system. Regular reporting the compliance situation to all regions and quality board. Support some regulatory change management activities with product supply.

One year expat to work in different regulatory operation functions in headquarter in Germany. Including regulatory CMC variations, EU procedure lifecycle maintenance and global new products submission roll out.

Track and guide all regulatory activities within Bayer Health GloballyEnsure regulatory compliance for initial submission & approval and life cycle management of the product portfolioLeading a team to achieve high compliance rate of regulatory tracking and high dataquality in Regulatory information system

Submission Management for key development drug proejcts to ensure Regulatory Submission fulfill the reuqirements of global health authorities.Leading people in the team to achieve the coordination, compilation, publishing and dispatch of submission dossiers for assigned projects.Support global head in submission process harmonazation, cross-sites training, monitoring submission reuqirements update from regional health authority.

Drug registration for import drug

Drug formulation investigation