Contract

Senior Associate, Regulatory Operations

SalaryCompetitive
LocationBoston, Massachusetts, United States
SectorGeneral

Description

Senior Associate, Regulatory Operations

SUMMARY:

The Senior Associate, Regulatory Operations is responsible for various day-to-day functions related to document publishing, submission compilation, regulatory information management, and submission management among other tasks as required. Under the direction of the Senior Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs, MAA 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.

 

RESPONSIBILITIES:

  • Manage all regulatory submission publishing deliverables on a day to day basis to ensure successful execution of operational activities
  • Responsible for publishing all submission documents (like clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.) and prepare them to submission ready
  • Maintain proficiency and expertise with the eCTD publishing tools, processes and regulations associated with regulatory submissions
  • 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 regulations and Regulatory Technology and Operations
  • Attending internal team meetings to collect and organize potential upcoming publishing and submission tasks
  • Participate in creation, review and implementation of department SOPs, WIs, and checklists


QUALIFICATIONS:

  • 5+ years of direct Regulatory Operations experience with publishing, compiling, QC, Validating electronic submissions (IND, MAA, NDA, CTAs,..)
  • Microsoft Office Suite (key focus on Word, Excel and PowerPoint and Visio) , Adobe Acrobat, ISI/TRS Toolbox , eCTD publishing tools, archiving/ filing/RIM activities, Veeva Vault experience highly desired
  • Excellent verbal and written communication skills required
  • Ability to work in a fast-paced environment that is primarily timeline-driven
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