Regulatory Affairs Expert
hace 3 días
Global Regulatory Leadership
The Global Regulatory Affairs Lead provides global regulatory leadership of assigned programs, developing global regulatory strategies, including risk assessment and mitigation strategies. This role chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s) and is the single point of contact/single point of accountability within GRA on the Core Asset Team (CAT) and Medicines Development Team (MDT) for assigned programs.
Regulatory Pathways and Agency Meetings
This position champions the use of expedited regulatory pathways globally to accelerate patients' access. The Global Regulatory Affairs Lead attends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned programs and may present to Senior Leadership regarding assigned programs.
Collaboration and Oversight
The Global Regulatory Affairs Lead cooperates with other departments and affiliates within Sobi, regulatory authorities, partners, and regulatory consultants. This role participates in strategic and regulatory evaluations of in-licensing matters and may have direct oversight/management of Regulatory Affairs team members supporting assigned programs.
Main Contacts and Interactions
This position has main contacts and interactions with internal and external core interactions, including 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, as well as Regulatory Authorities, CROs, Consultants, and Partners.
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