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Biotech
Manage and oversee RA, IRB/EC and Third Body submissions for assigned projects in EMEA, plan submission strategy and timelines, ensure regulatory compliance of study documents, liaise with local teams and authorities, support CTIS/EU CTR activities, manage budgets, and participate in quality, risk management, audits, and inspections.
Biotech
Lead end-to-end delivery of Phase I/Ib clinical pharmacology studies, manage sponsors and cross-functional teams, own scope/timelines/budgets, mitigate risks, ensure compliance (TMF/CTMS/ICH-GCP), mentor teams, support bids and process improvements to scale early‑phase programs.
