Job Description:

• Schedule timelines and strategies for new dossier (chemical drugs and biologics), variation or response for query as per NMPA requirements and co-ordinate it with the Head Office.
• New dossier preparing and filing, mainly on reviewing new dossier as per NMPA requirements, ensure timelines are being followed; consolidation of final dossier and filing to NMPA.
• Finished BE notifications for BE tests, mainly reviewing notification dossier as per NMPA requirements, ensure timelines being followed.
• Filing products regulatory following up, and Making representations to NMPA from time to time in clarifying and seeking clarity on product registration process, queries  from CDE or PQC etc.

Requirements:

1. Bachelor or Master degree in pharmacy or related discipline.

2. Good communication, learning and computer operation skill.

3. Good at English writing, reading and speaking.

4. At least 8-10 years of working experience, and more than 5 years in regulatory affairs.