Principal Regulatory Affairs, Study Start Up Specialist

Develop the regulatory study submission strategy for the study(ies). Provide oversight and leadership in the management of regulatory documents for clinical study submissions to relevant authorities and IRB/IEC, both regionally and globally, ensuring alignment with country-specific requirements. Monitor timely document collection, processing, and status reporting to study teams and sponsors. Serve as a subject matter expert, delivering authoritative guidance to project teams on regulatory requirements for clinical studies. Lead and supervise all aspects of documentation processes, including TMF review, reconciliation, close-out, and archiving, ensuring full compliance with SOPs and industry best practices.