Jobs at Syncromune, Inc.

The Senior Manager of Regulatory Affairs supports U.S. and international regulatory activities for pharmaceutical, biotech, combination, and medical device products. Responsibilities include preparing and reviewing IND, BLA, and other regulatory submissions; developing submission strategies; managing regulatory risks; coordinating cross-functional filings; responding to agencies; maintaining documentation; and improving regulatory processes and SOPs. The role requires oncology experience, strong technical writing and editing skills, regulatory expertise, and the ability to manage multiple priorities.

Lead and manage complex immuno-oncology drug/device combination clinical trials from start-up through closeout. Oversee CROs and site interactions, ensure GCP/ICH/regulatory compliance, prepare study documents and reports, identify and mitigate risks, organize meetings and training, and manage site payments and monitoring activities.

Lead analytical strategy for drug substance and product across development and commercialization. Oversee method development, validation, transfer, and lifecycle management; provide technical leadership in separation science (LC/MS), guide CDMO/CTL activities, support regulatory submissions, ensure GMP/ICH/FDA compliance, and drive analytical innovation and cross-functional collaboration.