Submission Content Manager, Regulatory Affairs Operations

Submission Content Manager, Regulatory Affairs Operations

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond
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You can view our latest corporate deck and other presentations here .

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.

Your work will primarily encompass:

• 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

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.

• 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 Starting Pointe CTD templates or equivalent

• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Demonstrated leadership skills…