Responsibilities:
- Responsible for preparing, submitting, and maintaining regulatory filings for domestic and international regions, coordinating submission activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants), maintaining up-to-date information on regulatory requirements and product submissions
- Participate as Regulatory CMC representative in CMC project-related team meetings; will involve multiple CMC projects (investigational and commercial)
- Work with regulatory therapy area lead and SMEs on preparing the regulatory submission strategies, authoring and review of the submission content, creating and maintaining submission timelines in order to meet business objectives
- Capable of leading and coordinating the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely submissions
- Work with SMEs to provide timely responses to CMC questions from regulatory agencies
- Keep up to date on industry and regulatory trends as well as CMC-related regulatory requirements and/or national law, and communicate with CMC team
