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.
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 regulatory procedures and changes.
Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.
Direct interaction with regulatory agencies on routine matters.
Bachelors/Masters Degree in a scientific discipline or equivalent with a minimum 8 years of Regulatory Affairs experience.
Must have extensive experience and understanding of CMC requirements for Small Molecule drugs.
Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines.
A working knowledge of electronic publishing and file management systems, preferred.
Excellent understanding of Microsoft Windows, Office, Excel, Project, Outlook, and other common PC applications.
Excellent organizational, presentation, and decision-making skills, and analytical thinking/problem-solving/investigative skills are required.
Certified regulatory affairs professional would be desirable
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