Lexington, MA: Submission Specialist (226007)

Regulatory Affairs

Location: Lexington, MA (remote for the time being)

Duration: 6 Months (with a strong likelihood of extension into 2021)

Job Description:

An AP Bio client is looking for a submission specialist to assist with making documents submission ready, formatting, compiling into EDMS, bringing documents through QC/review process and other tasks related to various regulatory files. All candidates must have some familiarity/experience with eCTD, CMC, drug substance, drug product and regulatory submission documents as well as a scientific background. The ideal candidate is a quick learner who is comfortable using various tools like Microsoft Office Suite, Adobe PBS and ISR writer (not required to know, what must be able to learn quickly with provided training).


  • Undertake document formatting to ensure consistency with company and health authority submission ready standards
  • Review documents for submission-readiness and conformity company and health authority guidelines
  • Undertake the submission build activities for both paper and electronic regulatory submissions, ensuring submissions are built with submission-ready documents, creating intra-document links, performing quality check and validating compiled submissions, and finalizing submission by required dispatch date
  • Support authors with loading documents into EDMS and concatenation as required
  • Support training of authors/reviewers through guidance and expertise of system and tools for  efficient authoring and review process
  • Support the creation and maintenance of CMC submission templates
  • Maintain team compliance with company trainings and internal processes and standards
  • Collates source documents pertaining to regulatory filings/submissions on request
  • On occasion will QC selected CMC sections of regulatory filings


JOB ID# 226007

Start Date
Greater Boston

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