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Senior Associate, Regulatory Operations

Newton, MA 02459

Post Date: 05/31/2018 Job ID: 1980 Job Category: Clinical: Regulatory

The Senior Associate, Regulatory Operations is responsible various day-to-day functions related to document publishing, regulatory information management, and submission management among other tasks as required. Under the direction of the Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs and related amendments/supplements in eCTD format. The successful candidate will ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines. This role will coordinate and liaise with external submission vendors to manage submission compilation, validation and dispatch.

  • Electronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.)
  • Support various internal functional groups ensuring the compliant use of eCTD Authoring Templates
  • Primary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as required
  • Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications
  • Perform U.S. and international regulatory research tasks as related to Regulatory Technology and Operations
  • Attending internal team meetings to collect and organize potential upcoming publishing and submission tasks
  • Participate in Regulatory initiatives aimed at improving internal regulatory standards, systems and procedures
  • Participate in creation, review and implementation of department SOPs, WIs, guides and checklists
  • Special projects related to submissions metrics in the form of tracking, collating, analyzing and reporting of key submission statistics
  • Support ongoing eDMS reconciliation activities
  • Help drive eDMS initiatives, functionality testing and training efforts
  • Assist with other Regulatory and adjacent technology projects, as required

  • 5+ years of direct Regulatory Operations experience publishing, compiling, QC, Validating and coordinating electronic submissions
  • Electronic document publishing and eCTD experience is required
  • Microsoft Office Suite (key focus on Word, Excel and PowerPoint and Visio, Adobe Acrobat, TRS Toolbox (formerly ISI), archiving/ filing/RIM activities, Veeva Vault and authoring template experience highly desired
  • eCTD viewing, validating, and general regulatory submission project management experience preferred
  • Excellent verbal and written communication skills required
  • Ability to work in a fast-paced environment that is primarily timeline-driven
  • Ability to independently complete complicated and technical tasks using sound judgement within stated request period as well as work as part of a team environment

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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