Submission Content Manager, Regulatory Operations

About the Role >>> Submission Content Manager, Regulatory Operations 

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 either our Cambridge, Ma or San Francisco, Ca office and may require up to 15% travel. 

Your work will primarily encompass: 

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

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• 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 
• Experience with StartingPoint eCTD templates or equivalent 

 Experience: 

• 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
• Experience in building and submission of NDA and life-cycle management is highly desirable

Attributes: 

• 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  
• Excellent written and verbal communication skills 
• Excellent negotiation and organizational skills 

The base pay range for this position is expected to be $145,000 - $155,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1