Manager, Regulatory Affairs

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.

• Bachelor's/Master's 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.