CMC Manager/Senior Manager of RA

Complete review CMC filing dossier separately to ensure the documents meet regulatory requirements and suggest the solution for the gaps in dossier preparation to HO R&D

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Work with Regulatory PM to ensure the timely delivery of CMC submission documents.

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Coordinate the activities for dossier filing and CMC site audit etc.

Requirements:

1. PhD or Master in Chemistry, Pharmaceutical Sciences or related. Master with 6+ years of experience and PhD with 4+ years of experience in pharmaceutical industry, with hands-on knowledge of pharmaceutical development, such as Synthetic, Analytical, Pharmaceutical Preparation or Manufacturing (GMP) etc. CDE working experience as CMC reviewer is a plus.

2. Strong analytical skills in sorting information, formatting directions and problem solving. Great sense of logic thinking. Thorough knowledge of pharmaceutical industry regulations, and very familiar with NMPA guidelines

3. Good communication, learning and computer operation skills.

4. Good at English writing, reading and speaking.