Submission Content Manager, Regulatory Affairs Operations

Olema Oncology • Boston, MA

12d • $145,000 - $155,000 • Onsite

About The Position

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 position ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission. The role partners closely 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).
The ideal candidate has strong attention to detail, experience with document management and eCTD standards, and the ability to manage multiple concurrent submission activities in a fast-paced environment.
This role is based out of our Cambridge, MA office and may require up to 15% travel.

Requirements

• Bachelor’s degree is required
• Knowledge and experience of eCTD submissions
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking
• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Demonstrated leadership skills while working in a fast paced and changing environment
• Excellent written and verbal communication skills
• Excellent negotiation and organizational skills

Nice To Haves

• Experience with StartingPoint eCTD templates or equivalent
• Experience in building and submission of NDA and life-cycle management is highly desirable
• Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working
• Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines
• Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives

Responsibilities

• 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
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level