This job is responsible for overseeing the overall development, scientific excellence, ethics, and operations of clinical research at IVI, securing funding and maintain collaborative relationships internally and externally (Donors and collaborators) for effective translational research in order for IVI to deliver on its mission.
i.Lead or support regulatory activities for the assigned product portfolio
ii.Lead or support regulatory submissions for: New Drug/Biological Applications protocols, medical reports, efficacy and safety summaries for clinical trials as per international standards,
SmPC, Package inserts, Patient information leaflet and Technical reports including submission to NRA and WHO for Prequalification