Manager Regulatory Affairs

MedImmune is hiring Senior level Regulatory Affairs professionals.brbrResponsible for collection, preparation & assembly of documentation required for Investigational New Drug Applications (IND), Investigational Medicinal Product Dossiers (IMPD) & Clinical Trial Applications (CTA) for biologic oncology products.brbr* Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents & conduct of meeting rehearsals.brbr* Proactively identifies potential regulatory issues & recommends solutions to Regulatory Affairs management.brbr* Leads team(s) responsible for development of regulatory submissions within assigned product portfolio. Interacts with other project team members to ensure the timely preparation & receipt of information required for regulatory submissions. Interacts with internal & external partners as necessary to support product development.brbr* Monitors related corporate activities for regulatory compliance, including nonclinical, clinical, research & development/manufacturing.brbr* Conducts & analyzes regulatory research to underst& past precedence & the current competitive l&scape. Evaluates & communicate impact of relevant regional regulations, guidances, current regulatory environment & competitor labeling.brbr* Identifies priorities & key issues in complex situations & solves these problems with minimal assistance.brbr* Is conversant & able to influence colleagues in multiple scientific areas.brbr* Educates internal stakeholders on implications of regulations.brbr* Provides preparation & planning support for meetings with regulatory agencies.brbr* Supports the preparation of responses to complex questions & comments from regulatory agencies.brbr* Develops timeline for responding to inquiries from regulatory agencies & ensures issues are addressed in a timely manner.brbr* Identifies & appropriately communicates potential risks.