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Regulatory Operations Manager

Remote, MA

Posted: 11/28/2022 Industry: Scientific and Life Sciences Job Number: 15089

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Regulatory Operations Manager
 Hiring Organization: Connexion Systems & Engineering
  • Duration: Temp to Perm
  • Pay rate: $60-70/hr
  • Job Location: Remote (MA)
  • Job# 15089


RESPONSIBILITIES:
  • Format MS Word submission components in accordance with regulatory requirements
  • Provide eCTD/CTD publishing services including, rendering, bookmarking, hyperlinking, compilation, table of contents creation and QC regulatory submissions to Regulatory agencies
  • Create, update, and maintain submission templates that meet global regulatory requirements
  • Coordinate with Regulatory Affairs to establish submission timelines, obtain on-time deliverables and ensure regulatory compliance for planned submissions
  • Maintain regulatory submissions filing and Health Authority correspondence logs with tracking system
  • Write or review internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation (electronic or paper)
  • Understand current global regulatory submission standards, software validation concepts, and publishing best practices
  • Evaluation and implementation of internal procedures related to document control, folder structure and electronic archiving
  • Manage configuration, correspondence, and agency queries in Veeva RIMs
  • QC and file regulatory submission documents in eTMF

QUALIFICATIONS:
  • Bachelor's degree and 4+ years of experience with regulatory submissions, compiling eCTD submissions and Document level publishing, or equivalent combination of education and experience
  • Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
  • Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, MHRA, Health Canada, and ICH for regulatory submissions to ensure compliance
  • Experienced in MS Word, Excel, PowerPoint, and Adobe Acrobat, Veeva Vault RIMs
  • Experience with electronic document management software and publishing packages


 
 

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