1.Dossier operation including collection/status tracking/CMC assessment and mitigation support/submission/post approval activities support, etc.

2. Dossier/ AW/ cross check to keep accuracy & consistency within dossiers;

supporting on initiation of contract process, modify content if needed, process system application, external guidance proofreading etc.

3. Assess NPD claims that compliant with regulatory requirements.

4. Support monitoring regulatory intelligence and policy changes.

5. Support HA testing relevant affairs.

6. Other supportive affairs.