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.
- 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
- 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.