Director, Regulatory Operations
Keros Therapeutics
August 29, 2026
Remote friendly (Lexington, MA)
United States
Operations
Job Summary:
Reporting to the Head Regulatory Affairs, the Director of Regulatory Operations will establish and lead the Regulatory Operations function at Keros, leveraging Regulatory Operations expertise to support growing regulatory needs, including in-house publishing and working with external vendors.
Primary Responsibilities:
- Oversee Regulatory Operations deliverables, including Health Authority correspondence/submission archives, Veeva Vault RIM administration, submission management, and training of business processes
- Implement training strategies; develop training materials and lead training delivery for Vault RIM adoption
- Manage user groups/workflows; create and maintain archives of Health Authority interactions
- Develop/manage/distribute reports, dashboards, and templates
- Contribute to writing/reviewing/implementation of standards and procedures for regulatory information management
- Partner with IT and Quality to support system validation
- Maintain Vault RIM proficiency and stay current on regulations/best practices/guidelines related to RIM
- Provide eCTD/CTD publishing services (rendering, bookmarking, hyperlinking, compilation, table of contents creation, QC, submission publishing)
- Coordinate publishing deliverables; serve as primary point of contact for Regulatory Affairs/CMC/Labeling for major submissions (IND, BLA)
- Write/review internal work instructions and SOPs for submission preparation (electronic or paper)
- Create/update/maintain submission templates meeting global regulatory requirements
Qualifications:
- BA/BS or equivalent experience
- 12+ years in industry; 7+ years in regulatory operations
- Attention to detail; ability to work independently and cross-functionally with vendors
- Experience running large-scale RA projects in biotech
- Extensive knowledge of eCTD/e-publishing systems and regulatory management systems (e.g., Veeva RIM)
- Proficient in MS Word/Excel/PowerPoint/Adobe Acrobat and Veeva Vault RIMs
- Ability to thrive in a collaborative, fast-paced environment
Reporting to the Head Regulatory Affairs, the Director of Regulatory Operations will establish and lead the Regulatory Operations function at Keros, leveraging Regulatory Operations expertise to support growing regulatory needs, including in-house publishing and working with external vendors.
Primary Responsibilities:
- Oversee Regulatory Operations deliverables, including Health Authority correspondence/submission archives, Veeva Vault RIM administration, submission management, and training of business processes
- Implement training strategies; develop training materials and lead training delivery for Vault RIM adoption
- Manage user groups/workflows; create and maintain archives of Health Authority interactions
- Develop/manage/distribute reports, dashboards, and templates
- Contribute to writing/reviewing/implementation of standards and procedures for regulatory information management
- Partner with IT and Quality to support system validation
- Maintain Vault RIM proficiency and stay current on regulations/best practices/guidelines related to RIM
- Provide eCTD/CTD publishing services (rendering, bookmarking, hyperlinking, compilation, table of contents creation, QC, submission publishing)
- Coordinate publishing deliverables; serve as primary point of contact for Regulatory Affairs/CMC/Labeling for major submissions (IND, BLA)
- Write/review internal work instructions and SOPs for submission preparation (electronic or paper)
- Create/update/maintain submission templates meeting global regulatory requirements
Qualifications:
- BA/BS or equivalent experience
- 12+ years in industry; 7+ years in regulatory operations
- Attention to detail; ability to work independently and cross-functionally with vendors
- Experience running large-scale RA projects in biotech
- Extensive knowledge of eCTD/e-publishing systems and regulatory management systems (e.g., Veeva RIM)
- Proficient in MS Word/Excel/PowerPoint/Adobe Acrobat and Veeva Vault RIMs
- Ability to thrive in a collaborative, fast-paced environment