Job Summary

A company is looking for a Manager, Global Regulatory Affairs CMC.

Key Responsibilities:

• Manage and oversee GRA Change Controls process across PTC's product portfolio
• Coordinate the preparation of periodic regulatory documents
• Support regulatory leads in developing regulatory strategy and execution of regulatory submissions

Required Qualifications:

• Bachelor's degree in scientific discipline and a minimum of 1-3 years of Regulatory Affairs experience in a pharmaceutical or biotechnology environment
• Basic knowledge of the FDA, EMEA and ICH regulations and guidelines for CMC
• Proficiency with Microsoft Office, MS Project, Veeva, SharePoint and MS Teams
• Experience in project management and coordination in a cross functional setting
• Results driven and keen attention to details