Regulatory Operations Specialist I

Overview

About Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

The Regulatory Operation Specialist I will serve as an internal team member for electronic submission publishing projects, primarily in eCTD format. He/she will collaborate with colleagues and clients on routine, project related matters. The RegOps Specialist will be responsible for completing tasks assigned in order to support team members in meeting submission deadlines.

Responsibilities

• Prepare, compline, scan, render, and maintain regulatory submissions to regulatory health authorities
• Prepare documents for electronic submission publishing by using MS Word formatting, content templates or MS Word Styles as directed
• Publish documents by creating bookmarks and hyperlinks into submission files according to Synchrogenix and client policies
• Track document publishing progress for eCTD submissions by using Synchrogenix tracking tools
• Perform quality control reviews and follow Synchrogenix procedures to identify, document, and remediate findings
• Track and report time spent completing project tasks Finish \
• Generate meeting agendas, minutes and scheduling for project meetings with clients
  
  

• Bachelor’s degree or equivalent experience
• Strong computer skills, including proficiency with MS Office and Microsoft Word functionality in terms of formatting documents using content templates or MS Word styles
• 0-3 years of prior experience using software applications including Adobe Acrobat and MS Office working in a professional environment that demands high utilization of computer and communication skills
• Technical knowledge of US, CA and EU eCTD submission requirements or willingness to learn
• Excellent IT/computer skills
• Excellent written and verbal communication skills\
• Ability to compile regulatory submissions with supervision by team leader
• Work in a role that demands strong attention to detail and organizational skills in a fast-paced environment
• Use simple rules, common sense and experiences to identify issues in the work product