Manager, Regulatory Affairs Associate

Job description

Overview Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/interpretations. May determine methods and procedures on some assignments and may provide guidance to other lower-level personnel. Responsibilities: Coordinates regulatory workflow, provides regulatory support to the team, and tracks project timelines and budget. Provides ongoing regulatory support to the project team members. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies. Reviews and formats technical documents (pertaining to clinical, chemistry, manufacturing and controls, and non-clinical information). This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments. Participates in assigned Regulatory Affairs initiatives aimed at improving internal Idenix standards and tracking/control systems. Develops and maintains current regulatory knowledge and keeps abreast of...