Regulatory Affairs- Doc Control
Trenton Metro Area, NJ
BS with 3+ years experience in the pharmaceutical industry, with direct experience in electronic document management systems (EDMS) and electronic submission publishing (compiling, QC,)
Knowledge of regulatory processes and related tools (document management, publishing (eCTDXPress Preferred) etc.)
Support non-filing related regulatory operational activities both in the US and EU; maintains processes and procedures for document management and preparing regulatory submissions.
Provides day-to-day support and training for users on the global document management system (GRAPES)
Assume document operations responsibilities of Regulatory Affairs (prep of 1572s submissions, form population, import submissions into GRAPES for EU)
Reviews documents to ensure compliance with style guidelines, publishing standards and eSubmission Readiness to support expanding scope (ODDO pipeline, DMFs and marketing applications) on a global scale.
Maintains the business aspects of the GRAPES such as US User accounts, project dictionaries, document attributes, system structure and organization
Creates, reviews, and manages global electronic document management system procedures in cooperation with the Global GRAPES Team.
Works with functional areas to develop authoring templates and procedures for document creation in the electronic document management system
Assist in the compilation and publishing of report-level document and dossiers.
Participates in Global GRAPES Meetings and Teleconferences
Assists the AD, Regulatory Operations in all areas of responsibility, including interpreting and enforcing electronic regulatory submission standards, policies and operating procedure requirements.