Senior Manager, CMC Project Management, Sumitomo Pharma Oncology, Marlborough, MA will be responsible for CMC compliance and CMC technical operations. Will formulate and evaluate the regulatory strategy for conducting clinical, nonclinical, and in vitro studies. Will ensure compliance to the applicable national and regional regulation and prompt approvals for FDA meetings, IND, NDA (or any equivalent regulatory process) for studies. Will maintain and evaluate changes to regulatory documents associated with the approved clinical trials and provide updates to regulatory agencies to maintain submission goals, including annual IND report, registry of clinicaltrial.gov, IND information amendment, and protocol amendment. W