Manager/Director, CMC Regulatory

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The primary function for this position is to manage registration related daily activities for Pharmaceutical Sciences, such as China’s and US IND, NDA, IB documents writing and tracking.

Responsibilities:

  • Participate in establishing registration strategy for CMC activities. Monitor the execution of registration strategy and project progress.
  • Supervise CMC registration activities, including tracking the updates/amendment and reviewing submission documents.
  • Work with every functional areas in Pharmaceutical Sciences, including Analytical Development, Process Development and Formulation Development to monitor the changes and regulatory commitments.
  • Review CMC submission document package to ensure the method validation plans and reports to ensure that the du7ments meet regulatory requirements during different phases of product development.
  • Work with Regulatory Affairs to ensure the timely delivery of CMC submission documents.
  • Coordinate the activities for submitting regulatory documents

 

Qualifications:

  • PhD or Master in Chemistry, Pharmaceutical Sciences or related fields. Master with 7+  years of experience and PhD with 4+ years of experience in pharmaceutical industry, with hands-on knowledge of pharmaceutical development, and a proven 2+ years project management experience.  Overseas education and working experience is a plus.
  • Experience with CTD document writing.
  • 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 FDA, ICH, CFDA guidelines
  • Good communication skills and positive interpersonal skills.
  • Fluent English (oral and writing) communication skills.