Manager, Regulatory Operations
monterosatx· Regulatory
About this role
Overview
Monte Rosa Therapeutics is seeking a highly skilled Regulatory Operations Manager to join our team. The ideal candidate brings expert proficiency in eCTD submissions, vendor oversight, and document management standards. This role requires a proven ability to manage multiple concurrent submission activities while maintaining precision and speed in a fast-paced environment.
Responsibilities
- CRO & Publishing Oversight: Manage external vendors to ensure the high-quality, timely publishing and submission of regulatory dossiers (e.g., IND, DSUR, NDA, etc).
- Regulatory Archiving: Maintain the official regulatory record by archiving all filings and health authority correspondence to ensure audit and inspection readiness.
- Document Preparation & Formatting: Lead the preparation of submission-ready documents, ensuring strict adherence to PDF standards, including bookmarks, hyperlinks, headers/footers, and accessibility requirements.
- Ensure all submission components meet global technical standards, including PDF/A compliance, OCR/searchability, and file size limitations.
- Serve as the Subject Matter Expert (SME) for eCTD templates, providing cross-functional guidance and training to ensure document consistency.
- Oversee regulatory databases and tracking for agency commitments while leading the development of SOPs, work instructions, and other controlled documents.
- Additional duties and responsibilities as required.
Qualifications
- 5+ years of experience in Regulatory Operations within Pharmaceutical or biotech industry.
- Comprehensive knowledge and experience of eCTD submissions, US and global health authorities
- Deep understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking
- Expert-level knowledge of eCTD software and enterprise document management systems, RIM platforms (e.g., Veeva).
Frequently Asked Questions
What is the salary for the Manager, Regulatory Operations role at monterosatx?
The listed salary for this Manager, Regulatory Operations position at monterosatx is USD 120K–145K/yr. This is an FULL TIME role.
Where is the Manager, Regulatory Operations position at monterosatx located?
This Manager, Regulatory Operations role at monterosatx is based in Boston, MA, US. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Manager, Regulatory Operations role at monterosatx full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Manager, Regulatory Operations role in the Regulatory department at monterosatx.
Which team or department does the Manager, Regulatory Operations at monterosatx belong to?
This Manager, Regulatory Operations position is part of the Regulatory department at monterosatx. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Manager, Regulatory Operations position at monterosatx?
Click the "Apply Now" button on this page. You will be redirected to monterosatx's official application portal hosted on icims where you can submit your application directly.
When was the Manager, Regulatory Operations job at monterosatx posted?
This Manager, Regulatory Operations position at monterosatx was posted on Apr 24, 2026. Apply as soon as possible — early applications are often reviewed first.
Manager, Regulatory Operations
monterosatx · 💰 USD 120K–145K/yr
You'll be redirected to monterosatx's official application page on icims.