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
• Hands on experience with document level publishing of submission components (like clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.) and prepare them to submission ready
• Responsible for assembly, publishing and compilation of IND, NDA, MAA, CTA submissions using eCTD publishing tools
• Maintain proficiency and expertise with the eCTD publishing tools, processes and regulations associated with global regulatory submissions

• Direct experience with ISI ToolBox or any other document publishing tools

• Direct experience with eCTD tools like eCTDExpress, Docubridge, Veeva publishing
• Good understanding of eCTD ICH and regional guidance’s

• High level of experience with eCTD templates and Microsoft Office tools

• Technical knowledge of electronic publishing tools/document management systems and software
• 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
• 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 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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