Global Regulatory Lead

Single point of contact/single point of accountability within GRA on the Core Asset Team (CTA) and Medicines Development Team (MDT) for assigned program(s)Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s)Provides global regulatory leadership of assigned program(s)Develops global regulatory strategies, including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients’ accessAttends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s)May act as the European or US Regulatory Strategy lead (jointly with GRL role) depending on the complexity of the program and stage of developmentMay present to Senior Leadership regarding assigned program(s)Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultantsParticipates in strategic and regulatory evaluations of in-licensing mattersMay have direct oversight of Regulatory Affairs team members supporting assigned program(s). Develops and coaches direct reportsAuthority to approve services and costs within budget and delegation from Sobi authorized signatoriesReview regulatory SOPs as neededParticipate in operational excellence work (improvement projects) as neededMain contacts:Internal core interactions: All functions within Sobi, but in particular Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, Global Medical & Scientific Affairs, Project & Portfolio Management as well as Management Teams, Governance Teams and affiliates.External core interactions with: Regulatory Authorities, CROs, Consultants, Partners.May act as point of contact with US FDA or EMA