Submission Content Manager, Regulatory Operations
Olema Oncology, Boston, MA, United States
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 .
You can view our latest corporate deck and other presentations here .
About the Role: Submission Content Manager, Regulatory Affairs 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 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
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 Starting Pointe CTD 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
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olev.com; our careers page is olem.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payment of any kind, and does not make job offers without an in‑person interview.
#J-18808-Ljbffr
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 .
You can view our latest corporate deck and other presentations here .
About the Role: Submission Content Manager, Regulatory Affairs 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 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
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 Starting Pointe CTD 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
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olev.com; our careers page is olem.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payment of any kind, and does not make job offers without an in‑person interview.
#J-18808-Ljbffr