Dossier / Regulatory Submission Director 注册/药理总监

Key accountabilitie********
1. Search an******** pharmacological ******** safety data an********data for drug or consumer pro******** with topical products an********products as the focus
2. Independently prepare application documents for China filing inCh******** an******** filing in English including translation ofpharmacological ******** safety data an******** data from English intoCh******** or vice versa
3. Participate in project assessment an********, product due diligence;analyze the product’s pharmacological ******** safety data an********data
4. Other work as assigne******** the senior management
Requiremen********
1) Master or Ph.D. or MD degree in the relevant fiel******** medicine orlife sciences
2) Strong R&D experience an******** affairs experience a plus
3) Broa******** knowle******** in-depth understanding of the mechanismof action of me******** drug discovery an********, clinical ********an********-market drug performance monitoring.
4) Excellent written English an******** skills; familiar with literaturesearching both in Chinese an********; fluent oral English a plus
5) Ability to extract relevant data an******** in-depth analysis of thedata
6) Ability to clearly an******** articulate the information verballyan******** writing
7) Ability to recommen******** filing strategy an********/ influenceregulatory agencies
8) Familiar with Dossier requirements an******** format for Chinaan******** submissions
9) Proact******** comm******** rel******** a problem solver with senseof urgency an********-do attitude
10) Must be a team-player; collaborate well with internal an********stakeholders.