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.