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Research and Development, Shanghai | 11 Mar 2020

Manager/Director, CMC Regulatory

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

Responsibilities

  • Participate in establishing registration strategy for CMC activities. Monitor the execution of registration strategy and project progress.
  • Review CMC submission document package to ensure that the documents meet regulatory requirements during different phases of product development.
  • Supervise CMC registration activities, including tracking the updates/amendment and reviewing submission documents.
  • Work with every functional area in Pharmaceutical Sciences, including Analytical Development, Process Development and Formulation Development to monitor the changes and regulatory commitments.
  • Work with company’s Regulatory Affairs to ensure the timely delivery of CMC submission documents.
  • Track CMC-related regulatory requirements updates from health authorities

 

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.