RA CMC

该职位来源于猎聘 Roles and Responsibilities: Objectives/Purpose: With supervision, support the development and implementation of China CMC regulatory investigation, registration and post approval strategies for assigned compounds. Support Global Regulatory CMC, Global Regulatory, Pharmaceutical Development, and Commercial project teams for assigned products throughout clinical development and commercial life cycle; Develops a solid understanding of RA CMC regulations and guidelines, and participants in the development of strategies to enhance probability of regulatory success and regulatory compliance; Interacts and effectively communicates with other internal and external colleagues. Typical Accountabilities:

• With minimal supervision, executes and manages regulatory submission for assigned projects;
• With supervision, prepares CMC submission dossier, helps define CMC content requirements, ensure high quality CMC submission complying with external and internal requirement;
• With supervision, participates Health Authority interactions and support CMC consultation meetings preparation with Health Authority on CMC related matters;
• With moderate supervision, handle sample registration testing in NIFDC/IDC, to support related registration approval;
• With moderate supervision, support Health Authority on-site inspection on CMC RA related matters;
• Ensure line management is apprised of developments that may impact regulatory success, communicating in professional and timely manner;
• Evaluates change proposals for regulatory impact with supervision, and helps plan variations and amendments;
• Ensure compliance with all applicable SOPs, and local and international regulations. Job Requirements: Education, Behavioral Competencies and Skills: BS/BA Degree required with 4+ years of relevant Industry, academic or HA experience; advanced degree preferred; Experience with CMC regulatory and regulatory, or equivalent industry experience; Ability to understand, apply and articulate regulatory CMC requirements for drug development and post-market support initiatives required; Demonstrates attention to detail and problem-solving abilities; Exercise appropriate judgement when working with project teams; Excises good judgement in elevating and communicating actual or potential issues to line management; Excellent written and oral communication skills required.