Manager, Regulatory Affairs

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    "description": "<h2>Overview</h2>\n<p>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.</p>\n<h2>Responsibilities</h2>\n<p>Coordinates regulatory workflow, provides regulatory support to the team, and tracks project timelines and budget.</p>\n<p> </p>\n<p>Provides ongoing regulatory support to the project team members.</p>\n<p> </p>\n<p>Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.</p>\n<p> </p>\n<p>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.</p>\n<p> </p>\n<p>Participates in assigned Regulatory Affairs initiatives aimed at improving internal Idenix standards and tracking/control systems. </p>\n<p> </p>\n<p>Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes.</p>\n<p> </p>\n<p>Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.</p>\n<p> </p>\n<p>Direct interaction with regulatory agencies on routine matters.</p>\n<h2>Qualifications</h2>\n<p>Bachelors/Masters Degree in a scientific discipline or equivalent with a minimum  8 years of Regulatory Affairs experience.</p>\n<p> </p>\n<p>Must have extensive experience and understanding of CMC requirements for Small Molecule drugs.</p>\n<p> </p>\n<p>Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines. </p>\n<p> </p>\n<p>A working knowledge of electronic publishing and file management systems, preferred.</p>\n<p> </p>\n<p>Excellent understanding of Microsoft Windows, Office, Excel, Project, Outlook, and other common PC applications.</p>\n<p> </p>\n<p>Excellent organizational, presentation, and decision-making skills, and analytical thinking/problem-solving/investigative skills are required.</p>\n<p> </p>\n<p>Certified regulatory affairs professional would be desirable</p>",
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      "name": "Monte Rosa Therapeutics, Inc",
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