Submission Content Manager, Regulatory Affairs Operations

Role Summary

The Submission Content Manager plays a critical role within Regulatory Operations by preparing regulatory submission documents for final publishing and delivery to global health authorities. This role ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission, and partners with Regulatory Affairs, Medical Writing, CMC, Nonclinical, and Clinical teams to ensure high-quality, compliant, and timely regulatory submissions (e.g., INDs, NDAs, MAAs, amendments).

Based in Cambridge, MA, this role may require up to 15% travel. A strong attention to detail and experience with document management and eCTD standards are essential to manage multiple concurrent submissions in a fast-paced environment.

• Document Preparation & Formatting
  • Prepare and format submission-ready documents, including applying PDF standards, bookmarks, hyperlinks, headers/footers, and accessibility elements
  • Ensure all documents meet technical standards (e.g., PDF/A compliance, OCR/searchability, file size limits)
  • Verify that tracked changes, comments, draft watermarks, and metadata are removed before pre-publishing
  • Serve as a subject‑matter expert for the Starting Point templates and provide training, guidance, and support to cross‑functional teams on how to use these templates effectively
• Submission Assembly Support
  • Assist Regulatory Operations staff in assembling and preparing eCTD sequences for publishing
  • Coordinate with submission teams to confirm final document versions and readiness for publishing
  • Track and document issues, risks, and deviations, escalating as appropriate
  • Work closely with Regulatory Affairs, Medical Writing, CMC, Quality, and Clinical teams to ensure submission accuracy and completeness
• Quality Control & Compliance
  • Perform technical QC checks on documents prior to publishing, ensuring formatting, structure, and completeness
  • Develop publishing standards and guidelines in coordination with Regulatory Operations and Medical Writing
  • Ensure all pre‑publishing activities comply with company SOPs, regulatory guidelines, and eCTD specifications

• Required:
  
  Bachelor's degree
• Required:
  
  Knowledge and experience of eCTD submissions
• Required:
  
  Knowledge and experience with enterprise document management systems, preferably Veeva RIM
• Required:
  
  Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking
• Required:
  
  Experience with Starting Point eCTD templates or equivalent
• Required:
  
  Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Preferred:
  Demonstrated leadership skills while working in a fast paced and changing environment
• Preferred:
  Experience in building and submission of NDA and life‑cycle management is highly desirable
• Required:
  
  Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working
• Required:
  
  Influences the cross‑functional team to adapt fit‑for‑purpose solutions to meet the expected timelines
• Required:
  
  Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives
• Required:
  
  Excellent written and verbal communication skills
• Required:
  
  Excellent negotiation and organizational skills

• Bachelor's degree required

• Up to 15% travel may be required