CMC/Regulatory Affairs Project Manager
Due to tremendous growth, The FlexPro Group is looking for a strong CMC/Regulatory Affairs Project Manager to help continuously develop and enhance our portfolio of industry leading talent.
We are FlexPro! We are a niche project management consulting firm with a passion for getting quality products to patients safely and effectively.
Our Life Sciences clients include large global pharmaceutical giants as well as small biotechnology startups. They have entrusted us to bring their important projects to the finish line since 2008. We’ve been consistently ranked in the “Top Management Consulting Firms” list by the Philadelphia Business Journal year after year. We have received the “Corporate Culture Award” from Smart CEO, and have been recognized as “America’s Fastest Growing Private Company” by Inc. Magazine multiple times.
- Regulatory Experience with CMC Submissions for approval and international regulatory experience
- Create/maintain project plan according to regulatory activities
- Experience with dashboard creation for senior management
- Stakeholder management experience
- Able to handle a different countries/submission types
- Writing CMC submission experience or knowledge of components of CMC Regulatory filings