Medical Project Manager of Regulatory Affairs

Medical Project Manager of Regulatory Affairs (f/t); TopAlliance Biosciences Inc., Rockville, MD; Lead & coord reg affairs; coord planning, prep, & deliv of both IND & BLA submissions throughout the product's life cycle from pre-IND to BLA approval; serve as the contact between reg affairs project mngmnt & internal/external stakeholders for the specified projects; & execute & maintain submission delivery plans, submission content plans, & proactively provide status updates to all relevant parties. Master's degree in life science, w/ 3+ yrs exp in clinical operation req'd; knowl of ICH, GCP, FDA regs oncology therapeutics & reg affairs; Regulatory Affairs Certification (RAC) or Project Management Professional (PMP); w/ proficiency w/ Microsoft applications, & data tools, e.g. Word, Excel, PowerPoint, & SharePoint preferred. Mailing CV to: 9430 Key West Ave., Ste 125, Rockville, MD 20850